We don't predict approvals. We show you the facts.
pdufa.bio is built on one principle: give biotech catalyst traders the verifiable facts and the primary sources — not a black-box guess at whether a drug will be approved.
What we will never do
Per-drug approval probabilitiesNever
Buy / sell / position-size callsNever
Composite "bullish/bearish" scoresNever
Fabricated or unsourced dataNever
Some tools will tell you a drug has a "73% chance of approval" from a machine-learning model. We think that's exactly the kind of false precision that gets retail traders burned. Approval is binary and idiosyncratic; a single number hides far more than it reveals.
Outcome archiveSource-verified, with primary links
When we say a cohort of similar-cap PDUFAs moved a median ±X% on decision day, that's history, labeled as history — not a probability for the specific drug in front of you. When we mark a past decision "verified," it links to the FDA / SEC / company filing so you can check it yourself. When a label is still price-only, we say so.