WASHINGTON, October 2 — The FDA’s October 2026 decision calendar is relatively light compared to previous months, with a limited number of PDUFA dates scheduled. This follows a period of notable regulatory activity in September 2026, during which several rare disease treatments received approval. On September 3, Ionis Pharmaceuticals Inc.’s (IONS) Zanvastro was approved as the first drug to treat Alexander disease, a rare neurological disorder.
On September 17, Ultragenyx Pharmaceutical Inc.’s (RARE) gene therapy Fayuvi was approved as the first treatment for pediatric patients with Sanfilippo syndrome type A, a rare, progressive neurodevelopmental disease. On September 28, Egetis Therapeutics US Inc.’s Emcitate was approved as the first treatment for MCT8 deficiency, also known as Allan-Herndon-Dudley syndrome, a very rare genetic disorder.
From January through September 2026, 44 novel drugs have received FDA approval, compared to 32 novel drugs approved during the same period in 2025. The FDA is currently headed by Acting Commissioner Kyle Diamantas, J.D., following the resignation of Marty Makary as FDA Commissioner in May 2026 after roughly 13 months in office amid disputes over several FDA policy issues. On September 24, 2026, Heidi Overton, President Donald Trump’s nominee to lead the FDA, appeared before the Senate Health, Education, Labor, and Pensions (HELP) Committee for her confirmation hearing.
She faced questions on issues including the abortion pill mifepristone, the safety of the measles, mumps, and rubella (MMR) vaccine, and food safety. If confirmed, Overton, who is 37 years old, would become the youngest FDA commissioner in the agency’s history and its 28th Commissioner of Food and Drugs.
A video released on September 28, 2026, at 06:25 ET highlights five key FDA decisions scheduled for October 2026, covering potential approvals and expanded indications across oncology, rare diseases, ophthalmology, and chronic hepatitis B. The FDA issues monthly decisions on drug approvals, which are important milestones for biotech investors, companies, and patients. The article was published as Business News on September 28, 2026, and includes a contact for comments and feedback at [email protected].
