Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 5:03 AM ET
This page lists 110 FDA decision dates covering June 2026 to December 2026. 25 are still ahead, and 84 have been decided and are marked with the outcome. 1 passed its target date without a published decision. Each date comes from an FDA notice or a company filing, and where the source gives only a month or a quarter we say so instead of inventing a day.
A PDUFA date is the FDA's target date to complete review of a drug application, set under the Prescription Drug User Fee Act. It is a goal, not a promise: the agency can act before the date, on it, or after it.
A standard review carries a 10-month goal from the FDA's acceptance of the application; a priority review carries a 6-month goal. If the sponsor submits a major amendment during review, the FDA can extend the goal date by 3 months.
The FDA does not publish an official, forward-looking PDUFA calendar. Every date on this page comes from a company filing, press release or FDA notice, and each row links its source.
Of the 36 FDA decisions in 2026 on this site with both a sourced goal date and a sourced action date, 22 came before the goal date, 13 landed on it, and 1 came after. The largest early margin was 110 days (IBTROZI (taletrectinib) sNDA, Sep 16). Full record: FDA decision timing.
26 of the 79 decided rows on this page are archive decision records with no row in the API dataset; the API's 54 Decided rows in this window cover the other 53, counting a partner-held application once per listed ticker. Each archive row links its own sourced decision page.
On or around the goal date the FDA typically either approves the application or issues a Complete Response Letter explaining what stands in the way of approval. Decided rows below state the outcome in words and link the decision record.
Upcoming FDA PDUFA dates, updated November 5, 2026
Every upcoming FDA decision (PDUFA) date, drug, company, indication, run-up history, and market-cap cohort base rates. Tap any name for the full facts.
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Subscribing keeps it current: new dates and changes arrive automatically. 148 entries have a confirmed date and appear on that single day. 311 are guided only to a month or quarter, so they span that whole window and are prefixed with ~. We do not place an estimate on a specific day, because in a calendar app a guess looks exactly like a confirmed FDA date.
Run-up context, measured from a uniform T-120 baseline. Across 1,883 FDA decisions since 2020, the median peak gain from 120 trading days out was 18.0%, while the median move from T-120 to the day before the decision was 2.4%. The gap between those two numbers is the point: most of the move happens before the decision and is usually given back. 96% of events have a full T-120 window; the rest are excluded rather than back-filled. Full study. Past behaviour, not a forecast, and not investment advice.
June 2026
19 FDA goal dates in June 2026; 19 already decided, each row linking its source, updated November 5, 2026.
14 FDA goal dates in November 2026; 1 already decided, each row linking its source, updated November 5, 2026. 13 of them are still ahead, including IGALMI® (TEVA, Nov 14), Ivonescimab plus platinum-doublet (SMMT, Nov 14), BBP-418 (BBIO, Nov 27), Giredestrant (RHHBY, Nov 30) and Povetacicept (VRTX, Nov 30).
16 FDA goal dates in December 2026, 3 of them dated only to the quarter; 4 already decided, each row linking its source, updated November 5, 2026. 12 of them are still ahead, including Relacorilant (CORT, Dec 17), Giredestrant in combination with everolimus (RHHBY, Dec 18), Anito-cel (GILD, Dec 23), MR-107A-02 (VTRS, Dec 27) and Relutrigine (PRAX, Dec 27).