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