pdufa.bio

KEYTRUDA (pembrolizumab)

Updated ยทnext FDA decision on the calendar

KEYTRUDA (pembrolizumab) 3 FDA decisions on record below. Every date links its source.

MRK catalyst hub · PFE catalyst hub

About this program

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.

Catalyst history

PDUFA · Jun 12, 2026 ✓ ApprovedMRKPDUFA · Jul 10, 2026 ✓ ApprovedMRKPDUFA · Jul 10, 2026 ✓ ApprovedPFE

Questions

When is KEYTRUDA (pembrolizumab)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for KEYTRUDA (pembrolizumab); 3 FDA decisions are on record below.

What happened at KEYTRUDA (pembrolizumab)'s most recent FDA decision?

On Jul 10, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.