- Friday, December 5 is the PDUFA date for the FDA's review of Incyte's (INCY -1.7%) Jakafi (ruxolitinib) sNDA for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is currently approved for the treatment of myelofibrosis.
- Previously: FDA accepts Jakafi label expansion filing under priority review
PDUFA date approaches for Jakafi label expansion
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