Exactly what pdufa.bio tracks, how complete and how fresh it is, and: stated plainly: what it does not cover. Regenerated automatically on every data refresh.
1151
catalysts tracked
63
PDUFA / FDA decisions
1000
trial readouts
16
device milestones
469
companies (tickers)
98%
rows with a primary-source link
46%
PDUFA recall vs reference set
How we source it
ClinicalTrials.gov
958
SEC EDGAR (8-K/6-K/10-Q)
85
Earnings
72
Company press
15
Curated device seed
12
Curated foreign PDUFA
4
curated_pharma;colist
3
sec_edgar;colist
2
Date precision (we never fake a hard date)
Every date is tagged by how precisely it is known. Month/quarter/half items are estimates that shift and are shown as “(est.)”.
month
958
day
135
half
31
quarter
22
year
5
What we do NOT cover (known limitations)
• No per-drug approval probabilities. We refuse to invent one. Here's why. • Foreign / mega-cap PDUFAs that don't file clean US press releases are covered only via a small curated seed, not exhaustively. • Pre-IND and early-pipeline assets without a registered trial or filing are out of scope. • Quarter / half-year readout estimates are ClinicalTrials.gov primary-completion windows and move; treat them as ranges. • We drop our own junk. This refresh filtered 46 stale-alias rows and flagged 268 rows with no drug name rather than publish them.
Update cadence
The dataset is rebuilt from a primary-source crawl (SEC, FDA, and company IR) and hand-verified before publish. It is a snapshot, not a live tick: the homepage header shows the data-through date of the last full refresh, so currency is always stated, never assumed. See /sources.
Want the underlying data? The research datasets publish n-disclosed cohorts you can cite. A read-only feed / API is on the roadmap.