FDA Approves Aqvesme (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia
CAMBRIDGE, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients wit
FDA Approves Myqorzo (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy
SOUTH SAN FRANCISCO, Calif., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has approved Myqorzo™ (aficamt
FDA Approves Boncresa (denosumab-mobz), a Biosimilar to Prolia
BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership
FDA Approves Oziltus (denosumab-mobz), a Biosimilar to Xgeva
BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership
FDA Approves Nufymco (ranibizumab-leyk), an Interchangeable Biosimilar to Lucentis
Planegg-Martinsried, Germany - December 23, 2025 -- Formycon AG (FWB: FYB, Prime Standard, “Formycon”) and Bioeq AG (“Bioeq”) announce that the U.S. Food and Drug Administration (FDA) has approved Nuf
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
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