Why there is no approval rate here any more. This archive is a publishing record, not a sample. We verify recent and notable decisions first, so the verified subset is selected, not representative: its 2025 slice is 24 CRLs and no approvals, which says what we chose to check, not what the FDA did. The 307 unverified records have their outcome inferred from the share-price reaction, and they run 77% approved against 67% for the verified set, most likely because a stock that rose through a date gets read as an approval. Averaging either one would produce a confident number the evidence does not support.
For an actual FDA approval base rate, use the
run-up study, which is built for it: 1,883 PDUFA decisions, 2020 to 2026,
71.8% approved. Every record below links to its source, and unverified ones say so on the page.
Historical outcomes only, not a forecast for any pending decision.