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Monday, November 2, 2026

PDUFA CalendarOpen the FDA Predictor

Key numbers

  • Model status

    Not released

    Best candidate fda_iq@0.5.0: 3 of 9 release checks passed

    How estimates work

  • Drugs tracked

    711

    In the drug database, listings not yet reviewed included

  • Upcoming PDUFAs

    4

    Next 30 days

  • FDA decisions

    2

    Novel first-cycle decisions, last 30 days

Upcoming PDUFA dates

PDUFA dates in the next 30 days, soonest first
Drug / tickerCT-VCAP(Approve)PDUFADays to goWatchlist
CemdisiranREGN Generalized myasthenia gravis (gMG) No published CT-VCA scoreNot released: no approval estimate is shown28 days left in the periodDate not exact Sign in to save Cemdisiran to a watchlist
BXCL501Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetBTAIQ Agitation,Psychomotor, Bipolar I Disorder, Bipolar II Disorder, Schizoaffective Disorder, Schizophrenia No published CT-VCA scoreNot released: no approval estimate is shown12 days to go Sign in to save BXCL501 to a watchlist
IvonescimabNot yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetSMMT Non-Small Cell Lung Cancer, Metastatic Urothelial Carcinoma, Metastatic Urothelial Carcinoma (UC) No published CT-VCA scoreNot released: no approval estimate is shown12 days to go Sign in to save Ivonescimab to a watchlist
PovetaciceptVRTX IgA nephropathy (IgAN) No published CT-VCA scoreNot released: no approval estimate is shown28 days to go Sign in to save Povetacicept to a watchlist

Dates come from company and FDA disclosures and can change. P(Approve) stays “Not released” until a model passes its release checks. How estimates work

Model release checks

FDA approval model (FDA IQ)
Not released
Best candidate
fda_iq@0.5.0 sha256:0b83ea99…f233c
Release checks passed
3 of 9 release checks passed
Status
Serving blocked: no model has passed the release gates; the best candidate passes 3 of 9.

Estimates appear only after a model passes all nine release checks on past FDA decisions and a second admin approves it. Until then no drug shows a probability, a range or a confidence level.

FDA Predictor · Past FDA decisions · How estimates work

Recent FDA decisions

All decisions

Data provided by the U.S. Food and Drug Administration. Facts only: no estimate is shown for past decisions.

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