pdufa.bio

BRAFTOVI (encorafenib)

Updated ยทnext FDA decision on the calendar

BRAFTOVI (encorafenib) The FDA approved it on Feb 24, 2026. 1 FDA decision on record below. Every date links its source.

PFE catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

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 · Feb 24, 2026 ✓ ApprovedPFE

Questions

When is BRAFTOVI (encorafenib)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for BRAFTOVI (encorafenib); 1 FDA decision is on record below.

What happened at BRAFTOVI (encorafenib)'s most recent FDA decision?

On Feb 24, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has BRAFTOVI (encorafenib) been approved by the FDA?

Yes. The FDA approved an application for BRAFTOVI (encorafenib) on Feb 24, 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.