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Pembrolizumab

Updated ยทnext FDA decision on the calendar

Pembrolizumab is a Merck & Co., Inc. program. Its next catalyst is a Readout in Oct 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

Pembrolizumab is marketed as KEYTRUDA (pembrolizumab); the events below include those tracked under the brand name. Sponsor: Merck & Co., Inc. (MRK, PFE). We track 9 catalyst events for this program: 3 upcoming and 6 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 ✓ ApprovedPFEReadout · Sep 2026MRKReadout · Oct 2026MRKReadout · Dec 2026MRKReadout · Feb 2027MRK

Questions

When is Pembrolizumab's next FDA decision or readout?

The next tracked catalyst for Pembrolizumab is a Readout in Oct 2026.

What happened at 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.

Who makes Pembrolizumab?

Merck & Co., Inc. (MRK, PFE).

Has Pembrolizumab been approved by the FDA?

Yes. The FDA approved an application for 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.