pdufa.bio
CalendarDecisionsReadoutsPatents
Drug IndexStocksScreenerConferencesAdvisory Committees
StudiesRun-up by YearLearnGlossaryMethodologyAPIAccount
Pro

Jakafi XR (ruxolitinib)

Updated ยทnext FDA decision on the calendar

Jakafi XR (ruxolitinib) The FDA approved it on May 1, 2026. 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

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 · May 1, 2026 ✓ ApprovedINCY

Questions

When is Jakafi XR (ruxolitinib)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for Jakafi XR (ruxolitinib); 1 FDA decision is on record below.

What happened at Jakafi XR (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.

Has Jakafi XR (ruxolitinib) been approved by the FDA?

Yes. The FDA approved an application for Jakafi XR (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.

Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.
About · Corrections · Methodology

Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.

Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.

© 2026 pdufa.bio. All rights reserved.