Incyte faces delay on FDA's Jakafi decision for cGVHD; Bayer's Parkinson's cell therapy enters the clinic
Just 10 months after Incyte posted an upbeat assessment for Jakafi in a Phase III for chronic graft-versus-host disease, the FDA has opted to push back the sNDA to later in the year so it can address new data submitted for the supplemental approval request.
The new PDUFA date has now slipped back to Sept. 22.
According to Incyte, the agency pushed back the deadline after determining that the added info it had requested added up to a major amendment to the application.
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