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pdufa.bio

Palbociclib

Updated ยทnext FDA decision on the calendar

Palbociclib is a Roivant/Priovant program. Its next catalyst is a Readout in Oct 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

Palbociclib is marketed as IBRANCE (palbociclib); the events below include those tracked under the brand name. Sponsor: Roivant/Priovant (PFE). We track 2 catalyst events for this program: 1 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 · Jun 24, 2026 ✓ ApprovedPFEReadout · Oct 2026PFE

Questions

When is Palbociclib's next FDA decision or readout?

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

What happened at Palbociclib's most recent FDA decision?

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

Who makes Palbociclib?

Roivant/Priovant (PFE).

Has Palbociclib been approved by the FDA?

Yes. The FDA approved an application for Palbociclib on Jun 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.