pdufa.bio

ENHERTU (trastuzumab deruxtecan)

Updated ยทnext FDA decision on the calendar

ENHERTU (trastuzumab deruxtecan) 1 FDA decision on record below. Every date links its source.

AZN catalyst hub

About this program

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.

Catalyst history

PDUFA · May 15, 2026 ✓ ApprovedAZN

Questions

When is ENHERTU (trastuzumab deruxtecan)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for ENHERTU (trastuzumab deruxtecan); 1 FDA decision is 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.