Drugs.com - New Drug Approvals

1. FDA Approves Fayuvi (rebisufligene etisparvovec-hopf) Gene Therapy for the Treatment for Sanfilippo Syndrome Type A (MPS IIIA)

   NOVATO, Calif., Sept. 17, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the U.S. Food and Drug Administration (FDA) granted standard full approval of Fayuvi (rebisufligene etisparvovec-hopf), also known...

2. Bayer’s Kerendia (finerenone) Receives FDA Approval as the First New Treatment in 30 Years for Adults with Chronic Kidney Disease (CKD) and Type 1 Diabetes

   September 17, 2026 -- Bayer today announced that the U.S. Food and Drug Administration (FDA) approved Kerendia® (finerenone) to reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce the risk of sustained estimated...

3. FDA Approves Reduced Monitoring Time for First Two Doses of Imdelltra

   THOUSAND OAKS, Calif., Sept. 14, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) approved an update to the Imdelltra (tarlatamab-dlle) Prescribing Information that substantially reduces...

4. Biofrontera Announces FDA Approval of Ameluz Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma

   WOBURN, Mass., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today...

5. FDA Approves Bexlutry (lutetium Lu 177 dotatate) for Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors

   Boston, MA – 14 September, 2026 – Curium™ announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Bexlutry™ lutetium Lu 177 dotatate injection for the treatment of...

6. FDA Approves Pixclara (floretyrosine F 18) FET-PET Imaging Agent for Glioma

   Melbourne (Australia) and Indianapolis, IN (United States) | September 14, 2026 -- Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Pixclara®...

7. FDA Approves Omcazio (cabozantinib) Capsule Formulation for Administration Without Regard to Food

   SAN JOSE, CA AND TAIPEI, TW / September 11, 2026 / Handa Pharmaceuticals, Inc. (“Handa” or the “Company”) (TSE:6620) announced that the U.S. Food and Drug Administration (“FDA”) has granted final approval to...

8. FDA Approves Isembyld (apitegromab-mstn) Muscle-Targeted Treatment for Children and Adults with Spinal Muscular Atrophy (SMA)

   CAMBRIDGE, Mass.--(BUSINESS WIRE)--September 11, 2026-- Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its leading...