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FDA Approves Sephience (sepiapterin) for the Treatment of Children and Adults Living with Phenylketonuria

WARREN, N.J., July 28, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the U.S. Food and Drug Administration (FDA) has approved Sephience™ (sepiapterin) for the treatme

FDA Approves Anzupgo (delgocitinib) Cream for the Treatment of Chronic Hand Eczema

BALLERUP, Denmark, July 23, 2025 -- LEO Pharma, a global leader in medical dermatology, announced today that the U.S. Food and Drug Administration (FDA) has approved Anzupgo® (delgocitinib) cream (20

FDA Approves Kirsty (insulin aspart-xjhz), an Interchangeable Biosimilar to NovoLog

BRIDGEWATER, N.J., United States and BENGALURU, Karnataka, India: July 15, 2025 -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 53

FDA Approves Ekterly (sebetralstat) the First and Only Oral On-demand Treatment for Hereditary Angioedema (HAE)

CAMBRIDGE, Mass. & SALISBURY, England, July 7, 2025 (BUSINESS WIRE) -- KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has approved E

FDA Grants Accelerated Approval to Lynozyfic (linvoseltamab-gcpt) for Treatment of Relapsed or Refractory Multiple Myeloma

TARRYTOWN, N.Y., July 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for

FDA Approves Harliku (nitisinone) for the Treatment of Patients with Alkaptonuria

BOSTON, Massachusetts and Cambridge, UK – June 19, 2025 – Cycle Pharmaceuticals announced that the FDA has approved Harliku (nitisinone) Tablets for the reduction of urine homogentisic acid (HGA) in a

FDA Approves Yeztugo (lenacapavir) as the First and Only HIV Prevention Option Offering 6 Months of Protection

FOSTER CITY, Calif.--(BUSINESS WIRE) June 18, 2025 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo (lenacapavir)—the compa

FDA Approves Andembry (garadacimab-gxii) for Prophylaxis to Prevent Attacks of Hereditary Angioedema

KING OF PRUSSIA, Pa., June 16, 2025 /PRNewswire/ -- Global biotechnology leader CSL today announced the U.S. Food and Drug Administration (FDA) approved Andembry (garadacimab-gxii), the only treatment

FDA Approves Zusduri (mitomycin) for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

PRINCETON, N.J. -- (BUSINESS WIRE) -- Jun. 12, 2025-- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and sp

FDA Approves Ibtrozi (taletrectinib) for Advanced ROS1-Positive Non-Small Cell Lung Cancer

NEW YORK--(BUSINESS WIRE) June 11, 2025 -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U

FDA Approves Enflonsia (clesrovimab-cfor) for Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants

RAHWAY, N.J.--(BUSINESS WIRE) June 9, 2025 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved Enflonsi

FDA Approves Widaplik (telmisartan, amlodipine and indapamide) for the Treatment of Hypertension

London, UK, Boston, MA, 9 June 2025 -- George Medicines, a late-stage biopharmaceutical company focused on addressing unmet needs in cardiometabolic disease, today announces that the US Food and Drug