We track 5 catalyst events for this program: 0 upcoming and 5 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 Enhertu (trastuzumab deruxtecan)'s next FDA decision or readout?
No upcoming catalyst is on our calendar for Enhertu (trastuzumab deruxtecan); 5 FDA decisions are on record below.
What happened at Enhertu (trastuzumab deruxtecan)'s most recent FDA decision?
On May 15, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
Has Enhertu (trastuzumab deruxtecan) been approved by the FDA?
Yes. The FDA approved an application for Enhertu (trastuzumab deruxtecan) on May 15, 2026; 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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Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.