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pdufa.bio

Ruxolitinib

Updated ยทnext FDA decision on the calendar

Ruxolitinib is a Incyte Corp program. Its next catalyst is a Readout in Jun 2028. 1 FDA decision on record below. Every date links its source.

INCY catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Ruxolitinib is marketed as Jakafi XR (ruxolitinib); the events below include those tracked under the brand name. Sponsor: Incyte Corp (INCY). 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 · May 1, 2026 ✓ ApprovedINCYReadout · Jun 2028INCY

Questions

When is Ruxolitinib's next FDA decision or readout?

The next tracked catalyst for Ruxolitinib is a Readout in Jun 2028.

What happened at Ruxolitinib's most recent FDA decision?

On May 1, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Who makes Ruxolitinib?

Incyte Corp (INCY).

Has Ruxolitinib been approved by the FDA?

Yes. The FDA approved an application for Ruxolitinib on May 1, 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.