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FDA Drug Approvals

New drug approvals announced by the U.S. Food and Drug Administration, updated daily from the FDA press feed.

Updated 2026-10-28

Date Announcement Type
2026-10-20 FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment Approval
2026-10-20 FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women Approval
2026-10-19 FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery Approval
2026-10-14 FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer Approval
2026-10-01 FDA Approves First Heart Valve Designed to Grow with Children Approval
2026-09-28 FDA Approves First Treatment for MCT8 Deficiency Approval
2026-09-17 FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A Approval
2026-09-04 FDA Grants Accelerated Approval to a New Breast Cancer Treatment Accelerated approval
2026-09-03 FDA Approves First Drug to Treat Alexander Disease Approval
2026-08-28 FDA Approves First Drug of Its Kind for Polycythemia Vera, a Rare Blood Disorder Approval
2026-08-27 FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults Approval
2026-08-26 FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer Approval
2026-08-19 FDA Approves First Therapy for Patients aged 8 years and older with Glycogen Storage Disease Type Ia Approval
2026-08-06 FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma Approval
2026-08-05 FDA Approves First Drug to Treat the Full Range of Narcolepsy Type 1 Symptoms Approval

What changed

  • 2026-09-29: New approval (2026-09-28): FDA Approves First Treatment for MCT8 Deficiency
  • 2026-10-01: New approval (2026-10-01): FDA Approves First Heart Valve Designed to Grow with Children
  • 2026-10-20: New approval (2026-10-19): FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery
  • 2026-10-20: New approval (2026-10-14): FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
  • 2026-10-28: New approval (2026-10-20): FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment
  • 2026-10-28: New approval (2026-10-20): FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women

Compiled from public sources; every announcement links to the FDA press release. This page is general information, not medical advice, and it is not a substitute for individual care.