Drugs.com - New Drug Approvals

1. 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...

2. 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...

3. 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...

4. 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...

5. FDA Grants Accelerated Approval for Otarmeni (lunsotogene parvec-cwha) Gene Therapy for Genetic Hearing Loss

   TARRYTOWN, N.Y., April 23, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Otarmeni (lunsotogene parvec-cwha), the first...

6. Sanofi's Tzield Approved in the U.S. to Delay the Onset of Stage 3 Type 1 Diabetes in Young Children

   Paris, April 22, 2026. The US Food and Drug Administration (FDA) has approved the supplemental biologic license application for Tzield (teplizumab-mzwv), expanding the indication from eight years and older to as young as one year of age to delay the...

7. Sanofi and Regeneron’s Dupixent Approved in the U.S. as the First Biologic Medicine for Young Children with Uncontrolled Chronic Spontaneous Urticaria

   Paris and Tarrytown, NY, April 22, 2026. The US Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of children aged two to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1...

8. FDA Approves Idvynso (doravirine and islatravir) for the Treatment of HIV-1 Infection in Adults

   RAHWAY, N.J.--(BUSINESS WIRE) April 21, 2026 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved Idvynso, a new, two-drug single-tablet regimen of...