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FDA Approves Zycubo (copper histidinate) for Children With Menkes Disease

January 12, 2026 -- The U.S. Food and Drug Administration today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients. “With today’s action

FDA Approves Nereus (tradipitant) for the Prevention of Motion Sickness

WASHINGTON, Dec. 30, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration has approved Nereus (tradipitant), an oral neurok

FDA Approves Yartemlea (narsoplimab-wuug) for the Treatment of Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy

SEATTLE--(BUSINESS WIRE)--Dec. 24, 2025 -- Omeros Corporation (NASDAQ: OMER) today announced that the U.S. Food and Drug Administration (FDA) has approved Yartemlea (narsoplimab-wuug) for the treatmen

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