FDA novel drug approvals 2025

New molecular entities and new therapeutic biologics approved by FDA's CDER in 2025, from Drugs@FDA records (original applications of submission class Type 1, counted once per active ingredient). Each entry links to its Drugs@FDA record. New approvals can take several days to appear in Drugs@FDA; FDA's own list is Novel Drug Approvals for 2025.

46 novel approvals · Drugs@FDA data as of Oct 13, 2026.