We track 3 catalyst events for this program: 0 upcoming and 3 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
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Questions
When is PADCEV (enfortumab vedotin)'s next FDA decision or readout?
No upcoming catalyst is on our calendar for PADCEV (enfortumab vedotin); 3 FDA decisions are on record below.
What happened at PADCEV (enfortumab vedotin)'s most recent FDA decision?
On Nov 21, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
Has PADCEV (enfortumab vedotin) been approved by the FDA?
Yes. The FDA approved an application for PADCEV (enfortumab vedotin) on Nov 21, 2025; the decision page linked above carries the source.
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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