Drugs.com - New Drug Approvals

1. 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...

2. 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...

3. 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...

4. 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...

5. 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...

6. Breztri Approved in the US for Asthma as First and Only Triple Therapy for Patients 12 Years of Age and Older

   April 28, 2026 -- AstraZeneca’s fixed-dose triple-combination therapy Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) has been approved in the US for the maintenance treatment of asthma in adult...

7. Saphnelo Approved in the US for Subcutaneous Self-Administration as a New Autoinjector for the Treatment of Systemic Lupus Erythematosus

   27 April 2026 -- AstraZeneca’s Saphnelo (anifrolumab) has been approved in the US for self-administration as a once-weekly autoinjector, the Saphnelo Pen, for the treatment of adult patients with systemic lupus erythematosus (SLE) on top...

8. FDA Approves Caplyta (lumateperone) sNDA with Robust New Data Supporting Reduced Risk of Relapse in Schizophrenia

   TITUSVILLE, N.J. (APRIL 27, 2026) – Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) based on long-term data evaluating the safety and efficacy of...