At least 14 PDUFA dates on deck in October: Data Byte

At least 14 therapies have PDUFA dates in the month of October, three of which have been granted priority review by FDA.

FDA is slated to announce its first decision of the month Friday on a priority review of CD19 CAR T therapy Tecartus brexucabtagene autoleucel from the Kite Pharma Inc. unit of Gilead Sciences Inc. (NASDAQ:GILD). Tecartus is under review to treat B cell precursor acute lymphoblastic leukemia, which, if approved, would be its second indication. The therapy was approved for mantle cell lymphoma in July 2020 under the accelerated approval pathway...