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KEYTRUDA (pembrolizumab)

Updated ยทnext FDA decision on the calendar

KEYTRUDA (pembrolizumab) The FDA approved it on Jul 10, 2026. 5 FDA decisions on record below. Every date links its source.

MRK catalyst hub · PFE catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

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.

Catalyst history

PDUFA · Jun 13, 2025 ✓ ApprovedMRKPDUFA · Feb 20, 2026 ✓ ApprovedMRKPDUFA · 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); 5 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.

Has KEYTRUDA (pembrolizumab) been approved by the FDA?

Yes. The FDA approved an application for KEYTRUDA (pembrolizumab) on Jul 10, 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.