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Datopotamab Deruxtecan

Updated ยทnext FDA decision on the calendar

Datopotamab Deruxtecan The FDA approved it on May 22, 2026. 2 FDA decisions on record below. Every date links its source.

AZN catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

We track 2 catalyst events for this program: 0 upcoming and 2 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.

Catalyst history

PDUFA · Jan 17, 2025 ✓ ApprovedAZNPDUFA · May 22, 2026 ✓ ApprovedAZN

Questions

When is Datopotamab Deruxtecan's next FDA decision or readout?

No upcoming catalyst is on our calendar for Datopotamab Deruxtecan; 2 FDA decisions are on record below.

What happened at Datopotamab Deruxtecan's most recent FDA decision?

On May 22, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has Datopotamab Deruxtecan been approved by the FDA?

Yes. The FDA approved an application for Datopotamab Deruxtecan on May 22, 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.
About · Corrections · Methodology

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