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FDA Approves Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for the Treatment of EGFR-Mutated Non-Small Cell Lung Cancer

HORSHAM, P.A. (December 17, 2025) -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj),

FDA Approves Exdensur (depemokimab-ulaa) for the Treatment of Severe Asthma with an Eosinophilic Phenotype

Philadelphia, PA -- December 16 2025 GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment

FDA Approves Fesilty (fibrinogen, human-chmt) for the Treatment of Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency

Barcelona, Spain, December 19, 2025 -- Grifols, a global healthcare company and leading producer of plasma-derived medicines, today announced that its fibrinogen concentrate, Fesilty (fibrinogen, huma

FDA Approves Cardamyst (etripamil) Nasal Spray for Adults with Paroxysmal Supraventricular Tachycardia

MONTREAL and CHARLOTTE, N.C., Dec. 12, 2025 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today announced that the U.S. Food and Drug Administration (FDA) approved its first commer

FDA Approves Lerochol (lerodalcibep-liga) for Adults with Elevated LDL Cholesterol

CINCINNATI, Ohio – December 15, 2025 -- LIB Therapeutics Inc. (LIB), a privately held biopharmaceutical company with a singular focus on helping high-risk patients achieve their cholesterol goals, tod

FDA Approves Nuzolvence (zoliflodacin) for the Treatment of Uncomplicated Urogenital Gonorrhea in Adults and Adolescents

WALTHAM, Mass. -- (BUSINESS WIRE) -- Dec. 12, 2025 -- Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA), today announced that the U.S. Food and Drug Administration (FDA) h

FDA Approves Waskyra (etuvetidigene autotemcel) Gene Therapy for the Treatment of Wiskott-Aldrich Syndrome

December 10, 2025 -- Fondazione Telethon announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Waskyra, an ex vivo gene therapy for

FDA Approves Avance (acellular nerve allograft–arwx) for Nerve Discontinuities

ALACHUA, Fla. and TAMPA, Fla., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical technologies for the restoration of periph

FDA Approves Armlupeg (pegfilgrastim-unne), a Biosimilar to Neulasta

Mumbai, India and Naples, FL -- December 1, 2025: Global pharma major Lupin Limited (Lupin), today announced that the United States Food and Drug Administration (U.S. FDA) has approved Armlupeg™ (pegf

FDA Grants Accelerated Approval for Voyxact (sibeprenlimab-szsi) for the Reduction of Proteinuria in Adults with Primary Immunoglobulin A Nephropathy (IgAN) at Risk for Disease Progression

November 26, 2025 -- Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) today announce the U.S. Food and Drug Administration (FDA) has

FDA Approves Itvisma (onasemnogene abeparvovec-brve) Gene Replacement Therapy for Adults and Children Two Years and Older with Spinal Muscular Atrophy

EAST HANOVER, N.J., Nov. 24, 2025 /PRNewswire/ -- Novartis today announced that the US Food and Drug Administration (FDA) has approved Itvisma (onasemnogene abeparvovec-brve) for the treatment of chil

FDA Approves Osvyrti (denosumab-desu), a Biosimilar to Prolia

RALEIGH, N.C., Nov. 20, 2025 /PRNewswire/ -- Accord BioPharma, Inc., the specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies,