Drugs.com - New Drug Approvals
New drug approvals news from Drugs.com. Comprehensive, up-to-date drug news for consumers and healthcare professionals.
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argenx Announces U.S. FDA Approval Expanding Vyvgart and Vyvgart Hytrulo for Use in All Adult Patients Living with gMG
Amsterdam, the Netherlands – May 8, 2026 - argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced the U.S. Food and Drug... -
FDA Approves Ocrevus for Relapsing-Remitting Multiple Sclerosis In Pediatric Patients 10 Years of Age And Older
South San Francisco, CA - May 8th, 2026 - Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), has received U.S. Food and Drug Administration (FDA) approval of Ocrevus (ocrelizumab) intravenous (IV) infusion for the treatment of... -
Partner Therapeutics Announces Receipt of FDA Commissioner’s National Priority Voucher for Bizengri (zenocutuzumab-zbco) in NRG1 Fusion-Positive Cholangiocarcinoma
LEXINGTON, Mass. – May 06, 2026 – Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has awarded a Commissioner’s National Priority... -
Incyte Announces FDA Approval of Jakafi XR (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host Disease
WILMINGTON, Del.--(BUSINESS WIRE)--May 1, 2026-- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR™ (ruxolitinib) extended-release tablets for the treatment of adults with... -
FDA Approves Veppanu (vepdegestrant) for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer
NEW HAVEN, Conn., May 01, 2026 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today with its partner Pfizer Inc. (NYSE: PFE), announced that the U.S. Food and Drug Administration (FDA) has granted approval for Veppanu (vepdegestrant) for the... -
ADMA Biologics Announces FDA Approval to Expand the Label for Asceniv to Include Pediatric Immune Compromised Patients Two Years of Age and Older
RAMSEY, N.J. and BOCA RATON, Fla., May 04, 2026 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), a U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing... -
Axsome Therapeutics Announces FDA Approval of Auvelity (dextromethorphan HBr and bupropion HCl) for the Treatment of Agitation Associated with Dementia due to Alzheimer’s Disease
NEW YORK, April 30, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug... -
FDA Approves Langlara (insulin glargine-aldy), an Interchangeable Biosimilar to Lantus
PHILADELPHIA - May 4, 2026 - Lannett Company, Inc., Lanexa Biologics, a wholly owned subsidiary of Lannett, and Sunshine Lake Pharma today announced that the U.S. Food and Drug Administration (FDA) has approved Langlara (insulin glargine-aldy), as a...