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For best results when printing this announcement, please click on link below: Atara Biotherapeutics Reports that the Resubmitted Tabelecleucel (Tab-cel®) Biologics License Application Has Been Accepted by the U.S. Food and Drug Administration Prescription Drug User Fee Act (PDUFA) Target Action Date of March 31, 2027 I
Atara Biotherapeutics reports that the FDA accepted the resubmitted biologics license application for tabelecleucel (Tab-cel).
Partner Pierre Fabre Pharmaceuticals resubmitted the biologics license application after feedback from a Type A meeting in April. Atara said it expects to provide a revised anticipated PDUFA date when available.
Atara Biotherapeutics, Inc. (NASDAQ:ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today provided an update that its partner, Pierre Fabre Pharmac…