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Flatiron Health Attends the 2026 American Society of Genitourinary Cancers Symposium to Answer Oncology's Most Critical Questions

NEW YORK--(BUSINESS WIRE)--Flatiron Health today announced its presence at the American Society of Genitourinary Cancers Symposium happening from February 26-28, 2026, in San Francisco, California. Flatiron's real-world data and research capabilities are featured across multiple presentations, including 6 research acceptances spanning genitourinary cancers. A cornerstone of Flatiron’s presence at ASCO GU 2026 is the global prostate cancer and bladder cancer Panoramic datasets, which draw from o...
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Median Technologies to Host Webcasts Highlighting Strategic Advances Driving U.S. Deployment of eyonis® LCS

SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, “Median” or the “Company”), developer of eyonis®, a suite of artificial intelligence (AI) powered Software as Medical Devices (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, today announced that it will host two webcasts on February 26, 2026. The webcasts, titled “Transforming Lung Cancer Sc...
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Allurion Receives U.S. FDA Approval

NATICK, Mass.--(BUSINESS WIRE)--Allurion Technologies, Inc. (NYSE: ALUR), a pioneer in metabolically healthy weight loss, today announced that the U.S. Food and Drug Administration (FDA) has approved the premarket approval (PMA) application for the Allurion Gastric Balloon System, featuring the Allurion Smart Capsule. “Today’s approval is a watershed moment for Allurion and for obesity care in the United States,” said Dr. Shantanu Gaur, Founder and Chief Executive Officer. “Our goal is to deliv...
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Beren Therapeutics Announces FDA Acceptance of its New Drug Application for Adrabetadex in Infantile-Onset Niemann-Pick Disease Type C

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Beren Therapeutics P.B.C.®, the parent company of Mandos LLC® and leader in cholesterol trafficking biology and cyclodextrin-based therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for adrabetadex, an investigational cyclodextrin therapy designed to increase intracellular cholesterol trafficking in Niemann-Pick disease type C (NPC). If approved, adrabetadex would represent...
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ImmunityBio Reports 700% Year-Over-Year Revenue Growth, Expanded ANKTIVA® Approvals in Lung Cancer and Global Commercial Partnerships in 33 Countries with Label Expansion Plans Globally

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced full-year 2025 financial and operational highlights, including approximately $113 million in net product revenue for ANKTIVA, representing an approximately 700% increase year-over-year. The Company also reported a 750% increase in unit sales volume and a 20% quarter-over-quarter increase in net product revenue, demonstrating sustained commercial momentum. In parallel...
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Gilead Sciences to Acquire Arcellx to Maximize Long-Term Potential of Anito-cel

FOSTER CITY, Calif. & REDWOOD CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has entered into a definitive agreement to acquire Arcellx (Nasdaq: ACLX) for $115 per share in cash at closing and one contingent value right of $5 per share, which represents an implied equity value of $7.8 billion payable at closing. Arcellx is a biotechnology company focused on delivering a new class of innovative immunotherapies for patients with cancer and other incura...
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Virion Therapeutics Reports Broad and Sustained Anti-HBV Immunity Following a Single VRON-0200 Dose in the Majority of Chronically HBV-Infected Patients From its Phase 1b Study at CROI 2026

PHILADELPHIA--(BUSINESS WIRE)--Virion Therapeutics, LLC, a clinical-stage biotechnology company developing novel T cell-based immunotherapies that utilize checkpoint modifiers, today announced at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI), in Denver, CO, that a single intramuscular dose of VRON-0200, its novel, first-in-class, immunotherapy for HBV Functional Cure was able to “spark” and re-awaken durable HBV-specific immunity in the majority of chronically HBV-infe...
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Savara Announces the U.S. Food and Drug Administration (FDA) Filed the MOLBREEVI* Biologics License Application (BLA) in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)

LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, announced the FDA has filed for review the BLA for MOLBREEVI as a therapy to treat patients with autoimmune PAP. The FDA granted Priority Review with a PDUFA action date of August 22, 2026. “The FDA’s filing of the BLA marks another significant milestone for Savara and the autoimmune PAP community and brings us one step closer to a potential...
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Dr. Reddy’s Announces USFDA Acceptance to Review Its Biologics License Application (BLA) for Proposed Interchangeable Biosimilar, Abatacept

HYDERABAD, India--(BUSINESS WIRE)--Dr. Reddy’s announces USFDA acceptance to review its Biologics License Application (BLA) for proposed interchangeable biosimilar, Abatacept....
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ImmunityBio Partners with Biopharma and Cigalah Healthcare to Launch ANKTIVA® in Saudi Arabia for Bladder and Lung Cancer Patients

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced a partnership with Biopharma and Cigalah, two of the largest and most respected healthcare commercial and distribution companies in the Middle East, to launch ANKTIVA® (nogapendekin alfa inbakicept) in Saudi Arabia and, over time, across the broader MENA region. Under the agreement, Biopharma and Cigalah Healthcare will support the commercialization and distribution...