We track 1 catalyst event for this program: 0 upcoming and 1 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 DATROWAY (datopotamab deruxtecan-dlnk)'s next FDA decision or readout?
No upcoming catalyst is on our calendar for DATROWAY (datopotamab deruxtecan-dlnk); 1 FDA decision is on record below.
What happened at DATROWAY (datopotamab deruxtecan-dlnk)'s most recent FDA decision?
On Jun 23, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
Has DATROWAY (datopotamab deruxtecan-dlnk) been approved by the FDA?
Yes. The FDA approved an application for DATROWAY (datopotamab deruxtecan-dlnk) on Jun 23, 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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