Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 2:24 AM ET
The FDA approved 0 new drug or biologic applications and 1 efficacy supplement (new uses for approved drugs) in November 2026, per Drugs@FDA as read on 2026-11-12.
New drug and biologic applications · 0
None in Drugs@FDA yet.
New uses for approved drugs (efficacy supplements) · 1
Nov 5: the FDA approved an efficacy supplement for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj (human recombinant)), Janssen Biotech, BLA761433 SUPPL-2. FDA letter.
Source: openFDA drugsfda (the Drugs@FDA data), read 2026-11-12. openFDA trails Drugs@FDA by about a week, so the latest days of a month can be missing until the next read. Generic approvals (ANDAs), labeling-only and manufacturing supplements are not listed. ← October 2026 · all months · PDUFA decisions this month · decisions we tracked in 2026