Prodalim Continues Its Accelerated Strategic Transformation With the Acquisition of René Laurent, a Leading Beverage Flavours Company Based in Grasse area, France




Prodalim Continues Its Accelerated Strategic Transformation With the Acquisition of René Laurent, a Leading Beverage Flavours Company Based in Grasse area, France

ROTTERDAM, Netherlands–(BUSINESS WIRE)–Prodalim, a global leader in Juice and specialty ingredients solutions, announced today the acquisition of René Laurent, a leading beverage flavours company, from International Flavours & Fragrances Inc. (IFF).

Established in 1885 in Grasse area, the capital of the flavours and fragrances industry in southern France, René Laurent is a century-old, trusted brand specializing in beverage flavours solutions and unique aromatic Ingredients. The company partners with leading multinational customers and local champions in the beverage industry, offering deep expertise in complex, tailor-made flavour development, including syrups, liqueurs, naturals and coffee. Its extensive flavour library and distinctive in-house distillation and extraction capabilities make René Laurent a respected expert in complex and customized formulations.

René Laurent will become part of Prodalim’s Beverage Compounds business unit, strengthening Prodalim’s holistic beverage solutions platform. This integrated platform now spans juice-based compounds, multi-blends, functional compounds and flavour-based solutions, supported by a robust supply chain, advanced product development capabilities, and strong global commercial organization. Together, these capabilities will allow Prodalim to deliver a comprehensive one stop shop tailor-made offering to customers worldwide and further accelerate its profitable growth journey.

The acquisition of René Laurent marks another important milestone in Prodalim‘s accelerated strategic transformation to cement its position as a high-value innovation partner for the Food and Beverage industry.

As part of its transformation, Prodalim has reorganized its operations into three purpose-driven divisions:

• Juice Solutions – legacy business covering a one stop shop solution for juice producers, including sourcing, logistics, formulation and blending
• Specialty Ingredients & Solutions – covering taste ingredients such as essential oils, aromatic fruit-based essences (FTNF) and flavours, as well as beverage compounds solutions and functional ingredients, including citrus fibers and natural colors
• SOLOS – a premium de-alcoholization patent-based solutions servicing the NoLo industry

All divisions are supported by Prodalim’s vertically integrated, regenerative supply chain, anchored in circular economy principles. Through this approach, Prodalim empowers Food and Beverage brands to innovate with sustainability, functionality, and transparency at their core.

About Prodalim

Prodalim is a global leader in juice and specialty ingredients solutions, harnessing nature’s essence to craft healthier creations. With its tree-to-table supply chain and global footprint, the company develops sustainable, innovative solutions for the food and beverage industry, making a meaningful impact for people and planet.

Visit Prodalim at: www.prodalim.com

Contacts

sales@prodalim.com

FDA Approves IsoPSA® — Cleveland Diagnostics’ Novel Blood-Based Prostate Cancer Test




FDA Approves IsoPSA® — Cleveland Diagnostics’ Novel Blood-Based Prostate Cancer Test

IsoPSA Test Evaluates Prostate Cancer-Specific Structural Variants of the PSA Protein to Aid in the Diagnosis of High-Grade Prostate Cancer

CLEVELAND–(BUSINESS WIRE)–Cleveland Diagnostics, Inc., a pioneering, commercial-stage precision oncology company, announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s IsoPSA® in vitro diagnostic (IVD) kit through the Premarket Approval (PMA) process. IsoPSA is a blood-based test indicated as an aid in the decision for prostate biopsy for men ≥ 50 years of age with elevated PSA levels.

“FDA approval of our IsoPSA kit marks a significant milestone in Cleveland Diagnostics’ mission to help physicians and patients detect cancer early when it is most treatable and survivable,” shared Arnon Chait, PhD, company president and CEO. “We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide.”

FDA approval of the IsoPSA test was based on clinical evidence from a large-scale, prospective study conducted at 14 sites across the U.S. and data from supporting analytical validation studies.

Prostate cancer is the second most common cancer in American men, with 1 in 8 diagnosed during their lifetime. In the U.S., greater than 1 million men undergo prostate biopsies each year, yet up to 75% of those follow-up tests are negative for high-grade disease. This diagnostic gap subjects millions to invasive, costly procedures that can produce physical risks, emotional stress, and significant healthcare costs. IsoPSA helps close this gap, giving clinicians and patients a more accurate risk assessment and greater confidence in biopsy decision-making.

“As a practicing urologist, I see firsthand how the limitations of current PSA testing can lead to unnecessary procedures and anxiety for patients and appreciate the critical need for early and accurate risk assessment and testing,” added Dr. Aaron Berger, Chief Medical Officer and Director of Clinical Research at Associated Urological Specialists in Chicago. “IsoPSA represents a meaningful advancement, giving physicians a tool that improves risk assessment and helps us make more informed biopsy decisions with greater confidence.”

“FDA approval underscores the value and clinical utility of IsoPSA in distinguishing benign elevations of PSA from those due to high grade cancer,” said Dr. Eric Klein, Emeritus Chair of the Glickman Urological & Kidney Institute at Cleveland Clinic and Distinguished Scientist at GRAIL, Inc.* “I’m very pleased to see this milestone achieved; it represents the culmination of extensive study and test development over the past decade.”

The IsoPSA IVD kit leverages Cleveland Diagnostics’ IsoClear™ platform. This proprietary technology investigates protein biomarkers at a structural level in the blood to provide clinically relevant insights into disease state.

Cleveland Diagnostics has offered IsoPSA as a Laboratory-Developed Test (LDT) since 2020, and Medicare and a growing number of commercial payors now cover the test. IsoPSA is included in leading clinical practice guidelines, including the National Comprehensive Cancer Network (NCCN) Prostate Cancer Early Detection Guideline (2025) and the Early Detection of Prostate Cancer: American Urology Association/Society of Urologic Oncology Guideline (2023).

For more information and company news, visit ClevelandDx.com

About Cleveland Diagnostics, Inc.

Cleveland Diagnostics is a precision oncology company focused on changing the shape of cancer detection. The company has unlocked the diagnostic power of protein structure with its revolutionary IsoClear™ platform that enables novel diagnostics based on a cancer-specific, protein structure-based assessment using easy to execute tests within the clinical lab setting.

Learn more at ClevelandDx.com and IsoPSA.com.

*Dr. Eric Klein who is quoted in this release, is a shareholder of Cleveland Diagnostics, Inc.

Contacts

Media Contact:
Liz Robinson

CG Life

News@ClevelandDx.com

Investor Contact:

Ji-Yon Yi

Gilmartin Group

ir@clevelanddx.com

The Urgency Still Remains for HIV: AHF Poland Marks World AIDS Day




The Urgency Still Remains for HIV: AHF Poland Marks World AIDS Day

LUBLIN, Poland–(BUSINESS WIRE)–#HIVawareness–On the occasion of World AIDS Day 2025, AHF Poland reminds the public that the fight to end the HIV/AIDS epidemic is far from over. Every year, the world records as many as 1.3 million new HIV infections, a clear signal that we cannot afford to become complacent. Now is the time to rebuild public awareness, invest in prevention, ensure universal and easily accessible testing, guarantee stigma-free care, and maintain strong partnerships with people living with HIV/AIDS—both within our communities and beyond. World AIDS Day is observed annually on December 1.

Despite decades of progress against HIV, around 40 million people worldwide are still living with the virus, and women and girls account for more than half of all infections. Stigma and discrimination continue to deprive many of the care they need, and key populations, such as migrants and people experiencing homelessness, face significant barriers in accessing treatment. World AIDS Day observances aim to highlight these challenges and underscore the importance of keeping HIV/AIDS at the center of national and global public-health efforts.

“Europe is at risk of losing ground in the fight against HIV,” said Daniel Reijer, AHF Europe Bureau Chief. “While Western Europe has made steady progress, in Eastern Europe and Central Asia, the epidemic continues to grow. Europe is now the only region that has fallen behind globally. While HIV-related deaths have halved worldwide since 2010, they have risen by a third across the region. We need renewed political will and stronger health systems that prioritize testing, prevention, and care. This World AIDS Day, let’s reignite the urgency to end HIV everywhere in Europe—because HIV/AIDS is not over until that becomes the reality.”

“The lack of universal health education, including sexual health, and the exclusion of disadvantaged groups—such as migrants or people experiencing addiction crises—from prevention, testing, and treatment efforts is a direct path to disaster,” adds Anna Szadkowska-Ciężka, Country Program Manager for AHF Poland. “Public health requires thoughtful strategies that tailor actions to the needs of specific social groups. This is precisely where AHF Poland focuses its work—reaching communities that are the hardest to reach with essential services.”

Additionally, pharma greed continues to block progress for the global HIV/AIDS response. Even with groundbreaking prevention tools like long-acting injectables, high prices keep them out of reach for the people and countries that need them most. True progress demands that pharmaceutical companies put people before profits because innovation doesn’t matter if it isn’t accessible to all.

World AIDS Day serves as a vital platform for HIV/AIDS advocates to acknowledge the progress made, remember those we have lost to AIDS-related illnesses and those who carry on the fight, and call on governments worldwide to commit the necessary resources and political support to end HIV/AIDS. On this World AIDS Day, we’re reminded: It’s Not Over.

AIDS Healthcare Foundation (AHF) is a global non-profit organization providing cutting-edge medicine and advocacy to over 2.7 million people in 50 countries worldwide in Africa, the Americas, the Asia/Pacific Region, and Europe. We are currently the largest non-profit provider of HIV/AIDS medical care in the world. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare.

Contacts

POLAND MEDIA CONTACT:

Anna Szadkowska-Ciężka

Country Program Manager

AHF Poland

anna.szadkowska@ahf.org

US MEDIA CONTACT:

Ged Kenslea, Senior Director, Communications, AHF

+1 323.308.1833 work +1.323.791.5526 mobile

gedk@aidshealth.org

Denys Nazarov, Director of Global Policy & Communications, AHF

+1 323.308.1829

denys.nazarov@aidshealth.org

L&T Technology Services Transforms Respiratory Diagnostics with NVIDIA AI-Powered Digital Twin Technology




L&T Technology Services Transforms Respiratory Diagnostics with NVIDIA AI-Powered Digital Twin Technology

Collaboration brings together LTTS’ expertise in MedTech and NVIDIA AI infrastructure to deliver precision diagnostics and enhance patient care

CHICAGO–(BUSINESS WIRE)–$LTTS #AI—L&T Technology Services (BSE: 540115, NSE: LTTS), a global leader in AI, Digital & R&D Consulting Services, today announced the development of a next-gen AI-powered digital twin platform for respiratory diagnostics and lung navigation.

Combining LTTS’ expertise in platform engineering, AI-driven diagnostics, connected health systems and advanced imaging and visualization with cutting-edge NVIDIA AI infrastructure, LTTS aims to deliver scalable, low-latency solutions that enhance diagnostic precision and improve accessibility for healthcare providers worldwide.

To be unveiled at the Radiological Society of North America (RSNA) 2025, the LTTS solution integrates with CT imaging and leverages deep learning models to create a 3D digital twin of lung anatomy, providing visualization of airways, blood vessels, lung lobes and lesions. Powered by NVIDIA MONAI for medical image segmentation and NVIDIA TensorRT for optimized AI inference, the biological digital twin enables interactive visualization, precise path planning and navigation support for bronchoscopy, helping clinicians navigate complex procedures with greater efficiency.

LTTS’ deep domain engineering expertise in medical imaging and proprietary navigation systems ensures the platform transforms the snapshots taken into living breathing models that evolve with the patient, delivering intuitive, clinically meaningful simulations that mirror real-world anatomy. This helps transform surgical planning and advancing care for serious conditions such as lung cancer, COPD and infectious diseases.

“AI is reshaping what’s possible in diagnostics and medical technology,” said Alind Saxena, Executive Director and President of Mobility and Tech at L&T Technology Services. “Our collaboration with NVIDIA combines LTTS’ expertise in AI-driven diagnostics and predictive analytics, with NVIDIA’s powerful, modeling and visualization platform. This lets us engineer a digital twin platform that not only enhances diagnostic accuracy but also gives clinicians an immersive, real-time planning tool ultimately helping deliver better outcomes for patients around the world.”

“Working with LTTS to accelerate the development of AI-enabled medical technology demonstrates how NVIDIA is empowering the healthcare industry with accelerated computing and AI innovation,” said David Niewolny, Director of Business Development for Healthcare/Medical at NVIDIA. “LTTS is enabling transformative solutions that bring the vision of real-time AI and biological digital twins powered by NVIDIA to clinical practice – delivering interactive, real-time visualization and intelligent guidance to help clinicians provide higher-quality care and achieve better outcomes for patients.”

About L&T Technology Services Ltd

L&T Technology Services (LTTS) is a global leader in AI, Digital & ER&D Consulting Services. A listed subsidiary of Larsen & Toubro (L&T), we offer design, development, testing, and sustenance services across products and processes.

Purposeful. Agile. Innovation. is how we drive growth across the Mobility, Sustainability and Tech segments. Our customer base includes 69 Fortune 500 companies and 57 top ER&D companies across industrial products, medical devices, transportation, telecom & hi-tech, and process industries. Headquartered in India, we have over 23,670 employees across 23 global design centers, 30 global sales offices, and 105 innovation labs, as of September 30, 2025.

For more information, please visit https://www.LTTS.com/

Contacts

Media:
Aniruddha Basu

L&T Technology Services Limited

E: Aniruddha.Basu@LTTS.com

Samsung Bioepis Announces Launch of Denosumab Biosimilars, OBODENCE™ and XBRYK™, in Europe




Samsung Bioepis Announces Launch of Denosumab Biosimilars, OBODENCE™ and XBRYK™, in Europe

• OBODENCE™ (60 mg pre-filled syringe) and XBRYK™ (120 mg vial) become available across Europe as of December 2025 and January 2026, respectively
• Marks Samsung Bioepis’ 10^th and 11^th biosimilars launched in Europe and second and third product to be commercialized directly by Samsung Bioepis
• Launch reinforces Samsung Bioepis’ biosimilar leadership in Europe as it expands its portfolio into endocrinology and builds on its growing direct sales efforts

INCHEON, Korea–(BUSINESS WIRE)–#Biosimilar–Samsung Bioepis Co., Ltd. today announced the launch of OBODENCE™ (60 mg pre-filled syringe) and XBRYK™ (120 mg vial), denosumab biosimilars referencing Prolia and Xgeva. The products will be commercially available in Europe in December 2025 and January 2026, respectively.

“We are very thrilled to launch OBODENCE and XBRYK through our direct sales efforts. Osteoporosis remains a major challenge in Europe due to limited treatment options and affordability challenges. And bone-related events resulting from bone metastases significantly impact a patient’s quality of life, leading to death if not treated fast enough. Our biosimilars aim to improve access, enable timely care, and ease the financial burden on healthcare systems.”, said Linda Choi MacDonald, Executive Vice President and Global Head of Commercial Division at Samsung Bioepis. “With our proven track records, we’re confident that OBODENCE and XBRYK will deliver meaningful impact on patients and their communities.”

OBODENCE, referencing Prolia, has been approved for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

XBRYK, referencing Xgeva, has been approved for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone, and treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

In Europe alone, osteoporosis results in 4.3 million fragility fractures and health care costs reaching €56 billion annually. Due to the limited treatment options and affordability of the medications, less than half of women at high risk of fracture are treated.¹ In addition, skeletal related events (SREs) resulting from bone metastases can lead to severe pain, increased risk of death, increased health care costs and reduced quality of life.²

OBODENCE, the company’s first biosimilar in endocrinology, and XBRYK, the company’s third biosimilar in oncology, mark Samsung Bioepis’ 10^th and 11^th biosimilars available in Europe. They add to the company’s diverse therapeutic portfolio ranging from immunology, oncology, ophthalmology, hematology, and nephrology.

About OBODENCE (denosumab) in the European Union

Obodence 60 mg solution for injection in pre-filled syringe is indicated for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.

Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures.

Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

OBODENCE EU Important Safety Information

The EU Summary of Product Characteristics for OBODENCE includes the following Special warning and Precautions:

• Hypersensitivity
• Hypocalcaemia
• Renal impairment
• Skin infections
• Osteonecrosis of the jaw (ONJ)
• Osteonecrosis of the external auditory canal
• Atypical fractures of the femur
• Long-term antiresorptive treatment
• Concomitant treatment with other denosumab-containing medicinal products
• Hypercalcaemia in paediatric patients

These highlights do not include all the information needed to use OBODENCE safely and effectively. Refer to the Summary of Product Characteristics for OBODENCE’s full safety information.

About XBRYK (denosumab) in the European Union

Xbryk 120 mg solution for injection is indicated for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.

Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

XBRYK EU Important Safety Information

The EU Summary of Product Characteristics for XBRYK includes the following Special warning and Precautions:

• Hypersensitivity
• Hypocalcaemia
• Hypercalcaemia following treatment discontinuation in patients with giant cell tumour of bone and in patients with growing skeletons
• Renal impairment
• Osteonecrosis of the jaw (ONJ)
• Osteonecrosis of the external auditory canal
• Atypical fractures of the femur

These highlights do not include all the information needed to use XBRYK safely and effectively. Refer to the Summary of Product Characteristics for XBRYK’s full safety information.

# # #

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X, LinkedIn.

¹ International Osteoporosis Foundation. SCORECARD FOR OSTEOPOROSIS IN EUROPE: SCOPE 2021 Summary Report. Available at: https://www.osteoporosis.foundation/scope-2021. Accessed January 2025.

² So A, Chin J, Fleshner N, Saad F. Management of skeletal-related events in patients with advanced prostate cancer and bone metastases: Incorporating new agents into clinical practice. Can Urol Assoc J. 2012 Dec;6(6):465-70. doi: 10.5489/cuaj.12149. PMID: 23282666; PMCID: PMC3526633.

Contacts

MEDIA CONTACT
Yoon Kim, yoon1.kim@samsung.com
Anna Nayun Kim, nayun86.kim@samsung.com

GE HealthCare builds on a century of innovation to shape the future of radiology at RSNA 2025




GE HealthCare builds on a century of innovation to shape the future of radiology at RSNA 2025

• The company will showcase a wave of transformative innovations designed to address the most pressing challenges in healthcare, spanning the care journey across smart devices and drugs throughout disease states enabled by cloud and AI solutions.
• GE HealthCare has invested more than $3B in R&D since 2022, delivering an innovation renaissance across disease states to advance precision care.

CHICAGO–(BUSINESS WIRE)–At this year’s Radiological Society of North America’s (RSNA) 2025 Annual Meeting, GE HealthCare (Nasdaq: GEHC) will showcase a wave of significant innovations grounded by its legacy and deep, global commitment to advancing precision care. For more than a century, GE HealthCare has stood at the intersection of medicine and technology—helping clinicians see more, understand more, and do more for their patients. What began with some of the world’s earliest technology innovations in medical imaging has evolved into a strong, global focus to advancing precision care.

Solving industry challenges

Radiology departments worldwide are facing unprecedented pressure. In the coming years, healthcare providers are expected to encounter several critical challenges, including a shortage of qualified staff, rising demand for imaging services, rapid technological advancements, and the urgent need to improve operational efficiency across care settings.¹ Amid these challenges, GE HealthCare is developing cloud-based and AI-enabled innovations aimed at helping providers and clinicians turn data into actionable insights, deliver precise diagnoses and treatment plans faster than before, and help hospitals boost their efficiency.

At RSNA 2025, GE HealthCare will showcase more than 40 technology innovations that merge state-of-the-art imaging device technology with advanced digital, computational and AI capabilities and are designed to address these challenges head-on: from AI-enabled imaging systems that are designed to reduce cognitive load and automate routine tasks, to structured reporting tools that can streamline workflows and improve data consistency.

“As we shape the future of care, our commitment remains clear: to deliver transformative technologies that empower clinicians, drive efficiencies, and help improve patient outcomes across multiple care pathways,” said Peter Arduini, CEO of GE HealthCare. “We start by listening to our customers, and work backwards from their challenges, then develop truly differentiated products and solutions to meet their needs today and into the future.”

Key products driving GE HealthCare’s innovation renaissance

GE HealthCare is delivering bold new solutions designed to elevate patient care and enhance the clinician experience. Since 2022, GE HealthCare has invested more than $3 billion in research and development, fueling a wave of innovation across equipment, radiopharmaceuticals and cloud and AI-enabled solutions. This year at RSNA, GE HealthCare will demonstrate new and recently announced innovations, including:

• Photonova™ Spectra² (510(k) pending with the U.S. FDA; not available for sale): The new photon counting CT (PCCT) system with advanced AI algorithms,³ marks a major milestone in the company’s decades-long history in CT innovation. Built on GE HealthCare’s proprietary Deep Silicon detector technology, Photonova Spectra is designed to deliver remarkable spectral and spatial resolution for ultra-high-definition (UHD) imaging with wide coverage, seeking to enable fast acquisition speeds, precise visualization of anatomical structures and enhanced material separation. This system is designed to maximize the vast amounts of data provided, harnessing up to 50 times more data than conventional CT⁴ to enable advanced reconstruction techniques and precise outputs with the aim of supporting enhanced clinical decision-making and smooth workflows.
• Next-gen SIGNA MRI technology (510(k) pending at the U.S FDA; not available for sale): These technologies are designed to enhance precision diagnosis for clinicians. The innovations include:
  • SIGNA™ Bolt⁵ aims to bring to market our most advanced high-field, clinical wide bore 3.0T MRI system and is seeking to combine ultra-high gradient performance, intelligent digital RF architecture, and sustainable design to deliver precision imaging, fast workflows, and seamless clinical-to-research flexibility, all with exceptionally low energy consumption and operational costs.
  • SIGNA™ Sprint with Freelium™⁶ aims to broaden access to sustainable and equitable MRI technology. With less than 1% helium usage compared to conventional magnets, Freelium is designed to provide effortless sustainability without compromising clinical and operational efficiency.
  • Both are powered by SIGNA™ One⁷, an AI-powered workflow platform designed to improve the imaging experience by combining precision with simplicity.
• Pristina™ Recon DL: This solution is GE HealthCare’s advanced 3D mammography reconstruction technology—the first to combine deep learning with iterative reconstruction to provide outstanding digital breast tomosynthesis (DBT) image quality at a low patient radiation dose. Pristina Recon DL is an enhancement to GE HealthCare’s Pristina Via™ system. Pristina Via with Recon DL mammography system offers high clinical confidence and efficient workflows with exceptional patient experience.
• Vivid™ Pioneer: GE HealthCare’s most advanced and adaptive cardiovascular ultrasound platform. With one-click optimization, AI automation tools, simplified user interface and a lighter, compact, battery supported system, Vivid Pioneer is designed for extraordinary imaging, workflow, and comfort.
• Flyrcado™ (flurpiridaz F 18) injection: FDA-approved PET MPI agent for adult patients with known or suspected coronary artery disease to evaluate myocardial ischemia and infarction; higher diagnostic efficacy versus SPECT, exercise-stress PET enabled by a longer half-life, and ready-to-use unit dose to support adoption. Flyrcado is expected to reach a substantial number of cardiac PET centers in the U.S. as adoption continues. CMS traditional pass-through status (effective Apr 1, 2025) supports access in HOPD settings. U.S. audiences only.
• Definium Pace Select ET: An advanced floor-mounted digital X-ray system designed to deliver high-image quality and optimize efficiency in highly demanding environments while enhancing access and affordability. The system solves for many technologist challenges today by automating manual, repetitive steps and helping to reducing physical strain. The system leverages AI to help ensure accurate patient positioning and consistent image quality across various clinical conditions while streamlining the technologist workflow to maximize the patient experience and throughput.

GE HealthCare is at the forefront of developing advanced AI- and cloud-enabled capabilities to help improve workflow efficiency for radiologists. Key highlights this year include:

• Genesis™ Radiology Workspace⁸ anchored by Genesis Viewer (510(k) pending at the U.S FDA; not available for sale):⁹ Software that is designed to be an ultra-fast diagnostic, zero-footprint viewer – streamlining radiology workflows and aiming to enhance patient care while being fully accessible from any location. Genesis Viewer is part of the GE HealthCare’s Genesis™ Radiology Workspace to help radiologists streamline their workflows. The next-generation solution is designed to transform radiology workflows, unify the user experience, and empower radiologists with great efficiency and precision.
• 100 FDA-authorized AI-enabled solutions: GE HealthCare leads the industry in artificial intelligence innovation, topping the FDA’s list for the most AI-enabled device authorizations of any medical device company this year. These solutions are helping to transform clinical workflows, supporting fast and precise decision-making, and expanding access to high-quality care.

“For more than 125 years, GE HealthCare has pioneered technologies that transform patient care. And while we celebrate our heritage, we remain focused on what lies ahead: a future where care is more personalized, connected, and intelligent than ever before,” said Roland Rott, CEO and President of Imaging at GE HealthCare. “This year at RSNA, our new innovations continue that tradition, empowering clinicians and advancing the boundaries of what’s possible in healthcare.”

A legacy rooted in discovery

GE HealthCare has been shaping the future of healthcare for more than a century. From the invention of the first x-ray tube still in use in modern day imaging equipment to today’s innovation renaissance, its led advances that redefine diagnostic imaging and how clinicians treat and care for patients. The company’s presence at every RSNA since its inception in 1914 reflects an enduring commitment to advance radiology and support the imaging community.

This year, GE HealthCare commemorates a series of transformative achievements that have shaped the landscape of medical imaging and patient care:

• Sixty years of mammography: Since 1965, GE HealthCare has led mammography innovation—from developing the first dedicated X-ray machine to digital, 3D, and AI-powered technologies that enable early accurate diagnoses. This ongoing commitment to women’s health empowers clinicians and aims to improve outcomes worldwide.
• Twenty-five years of PET/CT: Since introducing the world’s first commercially available PET/CT system in 2001—an innovation that would redefine diagnostic imaging and help transform patient care—GE HealthCare has expanded access and helped elevate precision medicine across care pathways. By combining functional and anatomical imaging, PET/CT has become an essential tool for clinicians, helping them detect, stage, and monitor cancer with greater accuracy and confidence.
• A legacy of industry firsts: GE HealthCare’s history is marked by groundbreaking achievements, including the development of the first full body CT scanner, the commercialization of magnetic resonance imaging (MR), the introduction of the first color pocket-size handheld ultrasound, Vscan, in 2010, and Flyrcado in 2024, a first-of-its kind PET molecular imaging agent for diagnosing and assessing coronary artery disease, a significant game-changing innovation for nuclear cardiology. Each innovation is designed to set new standards for patient care and clinical excellence.

Strategic collaborations driving innovation

GE HealthCare’s commitment to advancing patient care goes beyond research and development—it’s strengthened by strategic collaborations and acquisitions that accelerate innovation. In the past year, the company has strengthened its portfolio to include:

• MIM Software, which enhances GE HealthCare’s ability to provide advanced imaging analytics, visualization, and workflow solutions
• Spectronic Medical, delivering innovations that aim to enhance radiation oncology planning
• icometrix, which further expands GE HealthCare’s leadership in AI-enabled precision imaging, facilitating neurological disorder diagnosis and monitoring of disease progression

For more information on GE HealthCare and these innovative solutions at RSNA, visit booth 7334, explore the press kit, or the RSNA 2025 events page.

Important Safety Information and Usage of Flyrcado™ (flurpiridaz F 18) injection

Indications and Usage

FLYRCADO is a radioactive diagnostic drug indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction.

Contraindications

None

Warnings and Precautions

• Risk associated with exercise or pharmacologic stress: Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, stroke, and seizure. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent’s prescribing information.
• Radiation risks: FLYRCADO contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to patients and health care providers. Advise patients to hydrate before and after administration and to void.

Adverse Reactions

• Most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia.

Use in Specific Populations

• Pregnancy
  • There are no data on use of flurpiridaz F 18 in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from flurpiridaz F 18 and the gestational timing of exposure.
  • FLYRCADO contains ethanol (a maximum daily dose of 337 mg anhydrous ethanol). If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes associated with ethanol exposure during pregnancy.
• Lactation
  • Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for at least 8 hours after FLYRCADO administration.
• Pediatric Use
  • Safety and effectiveness of FLYRCADO in pediatric patients have not been established.

To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 800-FDA-1088 or www.fda.gov/medwatch

For full prescribing information, click here. For important safety information, please click here.

About GE HealthCare Technologies Inc.

GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient’s journey across care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits.

GE HealthCare is proud to be among 2025 Fortune World’s Most Admired Companies™.

Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com for more information.

¹ Elizabeth H. Dibble et al. “Workforce Shortage and Strategies for Mitigation: Results from the 2022 ACR/Radiology Business Management Association Workforce Survey.” Journal of the American College of Radiology 22, no. 5 (2025): 573–576. https://doi.org/10.1016/j.jacr.2025.01.xxx.

² Photonova Spectra is 510(k)-pending with the U.S. FDA. Not CE Marked. Not available for sale in the United States, Europe, Canada, or any other region.

³ Enhanced Boundary for PCCT is 510(k)-pending with the U.S. FDA. Not CE Marked. Not available for sale in the United States, Europe, Canada, or any other region.

⁴ When compared to Revolution Apex Elite.

⁵ SIGNA Bolt is 510(k) pending at U.S. FDA. Not CE marked. Not available for sale.

⁶ SIGNA Sprint with Freelium is a sealed configuration of SIGNA Sprint Select. SIGNA Sprint Select is 510(k) pending at U.S. FDA. Not CE marked. Not available for sale.

⁷ SIGNA One is 510(k) pending with the U.S. FDA. Not CE marked. Not available for sale.

⁸ Genesis Radiology Workspace consists of Genesis View, Enterprise Archive, Workflow Manager and App Orchestrator.

⁹ Genesis Viewer is 510(k) Pending at the U.S. FDA; not available for sale.

Contacts

Media Contact:
Catherine Carter

Senior Communications Manager

GE HealthCare

+1 414 396-1439

Catherine.Carter@gehealthcare.com

GE HealthCare unveils next-generation SIGNA MRI technology, aiming to boost efficiency, enhance patient experience, and advance sustainability




GE HealthCare unveils next-generation SIGNA MRI technology, aiming to boost efficiency, enhance patient experience, and advance sustainability

• SIGNA Bolt¹, a new 3T MRI scanner, is designed with a next-gen gradient system engineered to support precision diagnostics, clinical efficiency, and advanced research capability.
• SIGNA Sprint with Freelium,² a new sealed magnet MRI system, seeks to reimagine 1.5T MRI by combining a sustainable design with remarkable image quality, and operational autonomy to expand access to MR.
• Both new systems, 510(k) pending at the U.S. FDA, are powered by SIGNA One³, an ecosystem of AI-driven workflow solutions designed to reduce inefficiencies and support MRI exams from plan to scan and beyond.

CHICAGO–(BUSINESS WIRE)–GE HealthCare (Nasdaq: GEHC) today announced the 510(k) submissions to the U.S. Food and Drug Administration (FDA) seeking clearance for next-generation SIGNA™ MRI technology. Unveiled at the Radiological Society of North America’s 2025 Annual Meeting, these differentiated solutions are part of a wave of new GE HealthCare innovations aimed at tackling some of the most complex challenges in healthcare. Designed to enhance precision diagnosis for clinicians and help clinicians improve patient outcomes, the new technologies include GE HealthCare’s⁴ 1.5T MRI system, both equipped with an AI-powered workflow platform designed for end-to-end exam efficiency.

With imaging needs outpacing the radiologist workforce⁵, leading to longer wait times, burnout and delays in diagnosis, many departments are struggling to keep pace. At the same time, aging equipment and flat reimbursement rates are pushing providers to seek smarter, more sustainable solutions.

“The urgency for greater access, efficiency and precision in MRI has never been greater. We’ve listened to clinicians who are seeking smarter, more sustainable technologies to meet today’s challenges and tomorrow’s needs,” said Kelly Londy, President & CEO, MR, GE HealthCare. “With the introduction of our advanced SIGNA lineup, we’re delivering on a bold vision for MRI — one that intentionally puts smarter technology to work for clinicians and patients alike to make MRI more intuitive, more efficient, and more impactful in everyday care.”

SIGNA™ Bolt: Aiming to translate innovative discoveries and complex exams into everyday patient care

SIGNA Bolt⁶ aims to bring to market our most advanced high-field, clinical wide bore 3.0T MRI system and is seeking to combine ultra-high gradient performance, intelligent digital radio frequency (RF) architecture, and sustainable design to deliver precision imaging, fast workflows, and seamless clinical-to-research flexibility, all with exceptionally low energy consumption and operational costs.

SIGNA Bolt is designed to include:

• The power needed to deliver diagnostic quality in everyday scans with outstanding gradient and RF performance for both research and clinical applications
• Next-gen AI-enabled workflow of SIGNA One in combination with deep learning applications that are designed to enable accelerated examination times
• Deep-learning based advanced applications that aim to enhance diagnostic capabilities
• End-to-end clinical pathway solutions from planning to reporting for neurology and oncology
• Advanced developer toolkits to simplify research

SIGNA™ Sprint with Freelium™: Designed to be purposefully helium-free without compromising on clinical or operational efficiency

SIGNA Sprint with Freelium⁷ aims to broaden access to sustainable and equitable MRI technology. With less than 1% helium usage⁸, Freelium is designed to provide effortless sustainability without compromising clinical and operational efficiency.

Engineered for excellence, the SIGNA Sprint with Freelium 1.5T system is designed to support remarkable image quality through exceptional homogeneity, high signal-to-noise ratio (SNR) and image clarity. Integrated with deep learning solutions, including AIR™ Recon DL and Sonic DL with wide coverage of anatomies and clinical applications, the system aims to provide consistent clarity and diagnostic confidence.

Designed with flexibility in mind, its Freelium ventless magnet is designed to allow installation virtually anywhere – from inside hospitals to remote regions, expanding access to advanced MR capabilities for more patients and communities. SIGNA Sprint with Freelium features two levels of operational autonomy to empower radiology departments: Scanning Autonomy with SIGNA One Interface, an intuitive user interface aiming to simplify scanning for all levels of technologist experience, and Autoramp with intelligent sensors designed to support automated magnet recovery and supporting system uptime without the need for a field engineer.

SIGNA ™ Sprint with Freelium is designed to include:

• A design that uses less than 1% helium versus conventional designs⁹ with no additional power or cooling required
• MR magnet installation virtually anywhere – from inside hospitals to remote regions that need more access to advanced MR capabilities, due to its ventless design
• Exceptional homogeneity¹⁰ designed for impressive image quality and diagnostic capability

SIGNA One¹¹: Aiming to reduce inefficiencies with a new, AI-powered MRI workflow platform

A next-gen, AI-powered workflow platform that is designed to improve the imaging experience by combining precision with simplicity, SIGNA One offers five innovations at its core designed to streamline operations and elevate clinical confidence.

“We’re dedicated to making every interaction smooth, fast and patient centric by using predictive technology that boosts efficiency,” said Bryan Mock, PhD, General Manager, Global Product Segment, Premium MR, GE HealthCare. “SIGNA One technology is designed to simplify and improve the efficiency of experienced users, while aiming to shorten the learning curve for new users. Regardless of a users’ experience level, SIGNA One aims to liberate users from inefficiencies at every stage of the MR imaging process.”

SIGNA ™ One is designed to include¹²:

• An intuitive user experience that may help reduce training time and aims to boost productivity while aiming to shorten the learning curve for new and less experienced users
• The SIGNA One Table, designed to enhance patient comfort and simplify patient transport
• Fully automated SIGNA One Camera with In-Room Console live feed, AI-enabled landmark localization and patient positioning verification, with real-time visual guidance on a touchscreen display — aiming to improve speed and accuracy of patient setup
• Contactless respiratory and peripheral gating designed to capture physiological data effortlessly, regardless of patient orientation and without the need for external devices
• High-resolution, In-Room Consoles empowering technologists with simple patient setup control, aiming to minimize interruptions and maximizing throughput

GE HealthCare is integrating with NVIDIA technology to enhance the performance and intelligence of its MR products by utilizing NVIDIA GPUs to accelerate the development of deep learning reconstruction models. Accelerated by NVIDIA’s RTX product line and programmed with the new SIGNA One MRI Workflow solutions and advanced deep learning tools that are designed to elevate the user and patient experience, SIGNA Bolt and SIGNA Sprint with Freelium are designed to provide powerful imaging techniques for tailored patient care.

Learn more about these and other GE HealthCare MRI technologies at GE HealthCare’s booth #7334 at RSNA’s annual meeting in Chicago through Dec. 4.

About GE HealthCare Technologies Inc.

GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient’s journey across care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits.

GE HealthCare is proud to be among 2025 Fortune World’s Most Admired Companies™.

Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com for more information.

¹ SIGNA Bolt is 510(k) pending at U.S. FDA. Not CE marked. Not available for sale.

² SIGNA Sprint with Freelium is a configuration of SIGNA Sprint Select. SIGNA Sprint Select is 510(k) pending at U.S. FDA. Not CE marked. Not available for sale.

³ SIGNA One is 510(k) pending with the U.S. FDA. Not CE marked. Not available for sale.

⁴ Helium-free: Helium is permanently enclosed in the magnet.

⁵ Harvey L. Neiman Health Policy Institute, 2025.

⁶ SIGNA Bolt is 510(k) pending at U.S. FDA. Not CE marked, not available for sale.

⁷ SIGNA Sprint with Freelium is a sealed configuration of SIGNA Sprint Select, 510(k) pending at the U.S. FDA. Not CE marked, not available for sale.

⁸ Compared to conventional magnets.

⁹ Helium-free: Helium is permanently enclosed in the magnet

¹⁰ as conventional IPM magnet.

¹¹ SIGNA One represents features of SIGNA Bolt and SIGNA Sprint Select which are 510(k) pending at U.S. FDA. Not yet CE marked. Not available for sale.

¹² All features may not be included in all system configurations.

Contacts

GE HealthCare Media Contact:
Katie Scrivano

M +1 262-215-5281

Katherine.Scrivano@gehealthcare.com

Fifty Countries Strong: AHF ‘Keeping the Promise’ on World AIDS Day




Fifty Countries Strong: AHF ‘Keeping the Promise’ on World AIDS Day

M.O.U. cements Bangladesh as AIDS Healthcare Foundation’s newest country

Global nonprofit cares for over 2.7 million people worldwide; adds Tennessee and Michigan to U.S. roster

LOS ANGELES–(BUSINESS WIRE)–To mark World AIDS Day 2025, AIDS Healthcare Foundation (AHF) will hold major commemorative concerts and events in early December across Africa, Asia, Europe, and the Americas to emphasize that the work to end HIV/AIDS is far from over—underscored by the 1.3 million new infections that still occur globally each year.

World AIDS Day is observed annually on Dec. 1. AHF’s observances will promote HIV prevention, testing, condom access, treatment, and care, while demonstrating solidarity with people and communities affected by HIV/AIDS.

This year’s commemorations also coincide with a historic milestone for AHF: reaching operations in 50 countries worldwide, an extraordinary achievement since the organization first launched its global programs in 2002 in South Africa and Uganda. The recent signing of a memorandum of understanding (M.O.U) between AHF and the Government of the People’s Republic of Bangladesh cements that country as AHF’s newest.

“50 countries and 2.7 million lives in care: a remarkable accomplishment, one reached thanks to the dedication of thousands of AHF staff, volunteers, board members and with clients and patients who place their trust, and care, in our hands each day,” said AHF President Michael Weinstein. “However, in true AHF fashion we are not resting on our laurels. The global public health system is profoundly broken and must be repaired. STDs are at pandemic levels and being ignored. Too many patients are not retained in care. The responsibility of bringing as many people as possible into the lifeboat of care remains staggering but is a challenge AHF will continue to take on.”

In the United States, AHF also celebrates the addition of two states to its roster: Tennessee, where it recently opened a new AHF Healthcare Center in Memphis; and Michigan, where it just started operations and began treatment in Detroit. This brings AHF’s U.S. roster to include 19 states, Washington, D.C., as well as Puerto Rico. Over the past several years, the range of AHF services has also expanded to include food, shelter, disaster relief and wellness services.

Despite decades of progress in the fight against HIV, around 40 million people worldwide are living with the virus, with women and girls representing more than half of those affected. Stigma and discrimination continue to prevent many from accessing essential care, while key populations face significant barriers to treatment. These challenges are compounded by chronic underfunding of the global HIV response, highlighting the urgent need for sustained HIV/AIDS financing—including full funding of the Global Fund to Fight AIDS, Tuberculosis, and Malaria. AHF’s global World AIDS Day events will highlight these persistent gaps and reinforce the importance of keeping HIV/AIDS at the forefront of national and global public health priorities.

“This World AIDS Day reminds us that the fight against HIV is far from over. Millions of people still face barriers to testing, treatment, and ongoing care, while stigma and high drug prices put lifesaving tools out of reach,” said Terri Ford, AHF Chief of Global Advocacy & Policy. “Expanding access to prevention, including condoms and new innovations, supporting retention in care, and ensuring affordable treatment are critical to stopping new infections and saving lives. Governments and communities must work together to ensure progress is equitable for everyone living with or affected by HIV.”

Additionally, pharma greed continues to block progress for the global HIV/AIDS response. True progress demands that pharmaceutical companies put people before profits because innovation doesn’t matter if it isn’t accessible to all.

World AIDS Day serves as a vital platform for HIV/AIDS advocates to acknowledge the progress made, honor those we have lost to AIDS-related illnesses and those who carry on the fight, and call on governments worldwide to commit the necessary resources and political will to end HIV/AIDS. On this World AIDS Day, we’re reminded: It’s Not Over.

About AIDS Healthcare Foundation (AHF)

AIDS Healthcare Foundation (AHF) is a global non-profit organization providing cutting-edge medicine and advocacy to over 2.7 million people in 50 countries worldwide in Africa, the Americas, the Asia/Pacific Region and Europe. We are currently the largest non-profit provider of HIV/AIDS medical care in the world. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare

Contacts

US MEDIA CONTACT:

Ged Kenslea

Senior Director, Communications, AHF

+1.323.308.1833 work

+1.323.791.5526 mobile

gedk@aidshealth.org

Denys Nazarov
Director of Global Policy and Communications, AHF

+1 323.308.1829

denys.nazarov@aidshealth.org

CAR T-Cell Therapy for the Multiple Myeloma Market, 2025-2035: Extensive Data on Products, End Users, Regions and Companies – ResearchAndMarkets.com




CAR T-Cell Therapy for the Multiple Myeloma Market, 2025-2035: Extensive Data on Products, End Users, Regions and Companies – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “CAR T-Cell Therapy for Multiple Myeloma Market – A Global and Regional Analysis: Focus on Product, End User, and Region – Analysis and Forecast, 2025-2035” has been added to ResearchAndMarkets.com’s offering.

The chimeric antigen receptor (CAR) T-cell therapy has emerged as a groundbreaking treatment modality, offering new hope for patients with relapsed or refractory multiple myeloma (RRMM). Building upon traditional treatments such as autologous stem cell transplantation and monoclonal antibody therapies, CAR T-cells are engineered to recognize and destroy myeloma cells by targeting specific surface antigens. The recent approval of two CAR T-cell therapies – Abecma and Carvykti – by the FDA has demonstrated promising clinical outcomes, including high response rates and improved survival in heavily pretreated patients.

Ongoing clinical trials continue to investigate novel CAR constructs, combination strategies, and earlier-line use to further enhance efficacy and overcome existing limitations such as high costs, manufacturing complexity, and side effect profiles. These developments signal a transformative shift in Multiple myeloma treatment and pave the way for more personalized and effective therapeutic approaches.

The CAR T-Cell Therapy for Multiple Myeloma market is primarily driven by the high efficacy of BCMA-targeted therapies such as Abecma and Carvykti, which have demonstrated deep, durable responses in relapsed or refractory cases, significantly outperforming traditional treatment options. Additionally, the rising global incidence of multiple myeloma, particularly among aging populations, is increasing the demand for advanced, personalized treatment approaches.

Regulatory agencies like the FDA and EMA are further propelling market growth by granting fast-track approvals and priority designations to CAR T therapies, recognizing their transformative potential. Moreover, substantial investments from pharmaceutical giants and biotech firms in manufacturing capabilities, research and development, and clinical infrastructure are accelerating the commercialization and accessibility of CAR T-cell therapies worldwide.

Despite its therapeutic promise, the CAR T-Cell Therapy for Multiple Myeloma market faces several significant challenges. One of the most pressing issues is the high cost of treatment, often exceeding USD 400,000 per patient, which poses substantial reimbursement hurdles and limits affordability – particularly in low- and middle-income countries. The complex and individualized manufacturing process further adds to the burden, creating supply chain bottlenecks and scalability issues that hinder widespread adoption.

Additionally, CAR T-cell therapies are associated with severe side effects such as cytokine release syndrome (CRS) and neurotoxicity, necessitating intensive care and restricting use to highly specialized treatment centres. In many developing regions, limited healthcare infrastructure, a shortage of trained personnel, and low awareness further constrain market expansion and equitable access.

The competitive landscape of the global CAR T-Cell Therapy for Multiple Myeloma market is rapidly advancing, fuelled by increasing demand for precision oncology treatments and breakthroughs in cell and gene therapy. The market, once limited to conventional therapies such as immunomodulatory drugs and proteasome inhibitors, is now witnessing a surge in innovation with the approval and commercialization of BCMA-targeted CAR T-cell products like Abecma and Carvykti. Leading biopharmaceutical companies, including Bristol-Myers Squibb, Johnson & Johnson (Legend Biotech), Novartis, and Gilead Sciences, are actively expanding their pipelines and scaling manufacturing capabilities to meet rising global demand.

Additionally, emerging biotech firms and academic spin-offs are entering the space with next-generation and allogeneic CAR T constructs, further intensifying competition. The growing number of strategic partnerships, licensing agreements, and M&A activities reflects a dynamic market environment focused on improving access, reducing production timelines, and enhancing therapeutic durability. As regulatory bodies worldwide offer accelerated pathways and supportive frameworks, the market is poised for robust expansion, especially as CAR T-cell therapies move into earlier lines of treatment and explore novel antigen targets beyond BCMA.

The CAR T-Cell Therapy for Multiple Myeloma market holds substantial growth potential, particularly through expansion in emerging markets such as India, China, and Latin America. Improvements in clinical infrastructure and local regulatory approvals – like NexCAR19 in India – are paving the way for greater access in cost-sensitive regions. Additionally, there is increasing momentum in diversifying the therapeutic pipeline beyond BCMA, with new targets like GPRC5D and FcRH5 offering treatment options for patients who relapse after BCMA-based therapies.

Advancements in manufacturing technologies, including automation, closed-loop systems, and point-of-care platforms, promise to enhance scalability and reduce turnaround times. Furthermore, integrating CAR T-cell therapy with combination treatments – such as checkpoint inhibitors or monoclonal antibodies – presents a promising strategy to extend response durability and reduce the risk of relapse, thereby broadening the clinical utility of these therapies.

Market Segmentation

Segmentation 1: by Product

• Abecma
• Carvykti
• Anito cel
• Elrexfio
• Others

Segmentation 2: by End Users

• Hospitals
• Cancer Treatment Centres & Specialty Clinics
• Long-Term Care facilities

Segmentation 3: by Region

• North America
• Europe
• Asia-Pacific

Companies Profiled

• Bristol-Myers Squibb Company
• Novartis AG
• Johnson & Johnson (Legend Biotech)
• Gilead Sciences
• Others

For more information about this report visit https://www.researchandmarkets.com/r/2y4leu

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

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Merck to Participate in the 8th Annual Evercore ISI HealthCONx Conference




Merck to Participate in the 8th Annual Evercore ISI HealthCONx Conference

RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Chirfi Guindo, chief marketing officer, Human Health, and Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, are scheduled to participate in a fireside chat at the 8th Annual Evercore ISI HealthCONx Conference on Tuesday, Dec. 2, 2025, at 9:10 a.m. ET.

Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contacts

Media Contacts:

John Cummins

john.cummins2@merck.com

Michael Levey

michael.levey@merck.com

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Steven Graziano

(732) 594-1583