This page lists 479 FDA decisions, 364 approvals and 115 Complete Response Letters, covering January 2025 to October 2026. Every decision has its own page carrying the source document and the share-price reaction we measured on the day.
Recent FDA decisions, approvals and Complete Response Letters, with decision-day move, run-up, reason and primary source where verified. Labels under active validation; cross-check filings.
What is in this archive
479 records
Sourced
353 link a primary source
Inferred
109 read from the price reaction
Unsourced
17 asserted, no source shown
What these mean. Sourced pages link the FDA notice, SEC filing or company release the outcome came from, so you can check them. Inferred pages say on their face that the outcome was read from how the stock reacted, not from a document. Unsourced pages assert an outcome and show you nothing; they are older entries we have not yet gone back and sourced, and we would rather count them honestly than fold them into a total. This split used to read "Verified 370 with a primary source", which counted the unsourced ones, because the old rule treated the absence of a disclaimer as evidence. Absence of a disclaimer is not evidence.
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: 1,862 PDUFA decisions, 2020 to 2026,
71.5% 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.