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August 5, 2014
07:41 EDTINCYIncyte says FDA accepts sNDA for Jafaki
Incyte Corporation announced that the U.S. FDA has accepted for filing the supplemental New Drug Application for ruxolitinib as a potential treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. The sNDA includes results from the RESPONSE Phase III trial, which were recently presented at the 2014 American Society of Clinical Oncology annual meeting. RESPONSE was conducted under a Special Protocol Assessment from the FDA. The Prescription Drug User Fee Act date for the sNDA for ruxolitinib is set for December 5, 2014.
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January 23, 2015
07:36 EDTINCYIncyte earns $25M milestone payment from Novartis for Jakavi
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