FDA accepts resubmitted BLA for Atara's tabelecleucel with 2027 target date

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Go back to FDA accepts resubmitted BLA for Atara's tabelecleucel with 2027 target date

Atara Biotherapeutics Reports that the Resubmitted Tabelecleucel (Tab-cel®) Biologics License Application Has Been Accepted by the U.S. Food and Drug Administration

October 14, 2026 8:05 AM EDT

Prescription Drug User Fee Act (PDUFA) Target Action Date of March 31, 2027

If Approved, Tab-cel Would Be the First Therapy Available in the U.S. for EBV+ PTLD

THOUSAND OAKS, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel... More