What powers pdufa.bio, how often it updates, and what it does and doesn't cover. We publish our own metadata because a data source of record should.
Primary sources
FDA decision dates & outcomesFDA / company 8-K, 6-K, press releases; openFDA
Trial status & readout timingClinicalTrials.gov API v2
Price & volumeFinancial Modeling Prep
Options (implied move, IV)ORATS
Cash runway & filingsSEC EDGAR (10-Q/10-K/8-K)
Update cadence
Price, options and registry status refresh roughly 5×/day (snapshot, not a live tick). FDA decision dates are checked against primary filings on an ongoing basis. Each catalyst carries a source type and a confidence level.
Coverage & honesty
We track upcoming U.S. FDA decisions (PDUFA) and a growing set of clinical readouts; the historic archive is being expanded and source-verified in batches — outcomes not yet verified are labeled price-only, not 'verified.' We are not affiliated with the FDA, we do not estimate per-drug approval probabilities, and every date can slip — verify against the primary filing. See our methodology.