Drugs.com - New Drug Approvals

1. Novartis Rhapsido (remibrutinib) Receives FDA Approval as First Treatment for Symptomatic Dermographism

   Basel, October 7, 2026 – Novartis announced today that the U.S. Food and Drug Administration (FDA) approved Rhapsido® (remibrutinib), an oral, highly selective Bruton’s tyrosine kinase inhibitor (BTKi), as the first treatment for...

2. Pfizer’s Tukysa Regimen Receives FDA Approval as Front-Line Maintenance Treatment for HER2+ Metastatic Breast Cancer

   NEW YORK--(BUSINESS WIRE) October 7, 2026 -- Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Tukysa (tucatinib) in combination with trastuzumab and pertuzumab for the maintenance treatment of...

3. Lilly's Jaypirca (pirtobrutinib), the First-and-Only Approved Non-Covalent BTK Inhibitor, Receives Expanded Indication from U.S. FDA for Certain Patients with Previously Untreated CLL/SLL

   INDIANAPOLIS, Oct. 2, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved an additional indication for Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets), a...

4. U.S. Food and Drug Administration Approves Expanded Indication for Bristol Myers Squibb’s Camzyos (mavacamten) for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) in Adults and Pediatric Patients*

   PRINCETON, N.J.--(BUSINESS WIRE) September 30, 2026 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic...

5. FDA Approves Emcitate (tiratricol) for the Treatment of Patients with MCT8 Deficiency

   STOCKHOLM, SWEDEN, Sept. 28 2026. (GLOBE NEWSWIRE) – Egetis Therapeutics AB (publ) ("Egetis" or the "Company") (Nasdaq Stockholm: EGTX) today announced that the U.S. Food and Drug Administration (FDA) has approved Emcitate (tiratricol), a...

6. FDA Approves Degevma (denosumab-adet), a Biosimilar to Xgeva

   TEL AVIV, Israel, and PARSIPPANY, N.J., Sept. 28, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved Degevma (denosumab-adet) as a...

7. FDA Approves Juvmo (tavapadon) for the Treatment of Parkinson's Disease

   NORTH CHICAGO, Ill., Sept. 28, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved Juvmo (tavapadon) tablets as the first and only selective D1/D5 receptor agonist for the treatment...

8. Meitheal Pharmaceuticals Announces FDA Approval of High-Concentration Formulation of Yusimry, a Biosimilar to Humira

   CHICAGO--(BUSINESS WIRE) September 28, 2026 --Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago and focused on the development and commercialization of generic injectables...