SOUTH SAN FRANCISCO (dpa-AFX) - The FDA's November calendar has more than a dozen PDUFA dates on the horizon, setting the stage for an eventful month in the regulatory landscape.
Before turning to what lies ahead, let's look back at some of the regulatory developments that made headlines in October.
The month saw several notable milestones, including approvals that marked important firsts, from a growth-accommodating heart valve for children to new treatment options for bladder cancer and chronic hepatitis B.
On October 1, the FDA approved Edwards Lifesciences' Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve, intended for pediatric patients with congenital pulmonary valve disease. It is the first heart valve designed to be expanded after surgery to keep pace with a child's growth, and the first valve approved in the U.S. to use polymeric material rather than animal-derived tissue for its inner flaps (called leaflets).
On October 14, the FDA expanded the approval of Anktiva, developed by ImmunityBio Inc.'s subsidiary Altor BioScience LLC, to include patients with BCG-unresponsive, high-grade papillary-only bladder cancer that has not spread into the bladder muscle.
On October 20, the FDA approved GSK's Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, for certain adults with chronic hepatitis B virus (HBV) infection who do not have cirrhosis. Hibsago is the first FDA-approved antisense oligonucleotide for chronic hepatitis B.
October also brought regulatory clarity for digital health tools, ending longstanding uncertainty. As mobile apps become more widely used to manage medications and health conditions, it is important that the information they provide is accurate, evidence-based, and clear to both patients and healthcare providers.
On October 20, the FDA released its final guidance establishing a clear framework for how drug companies can develop, distribute, and label apps used alongside their prescription medicines. The guidance provides recommendations about when app content is subject to FDA submission requirements, when an app should be mentioned on a drug's official label, and what companies should submit to the agency.
Now, let's take a look at the biotech stocks facing FDA decisions in November 2026.
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