Brief: Pierre Fabre Pharmaceuticals On Jan 9, Got Complete Response Letter For Tabelecleucel BLA From U.S. FDA

Atara Biotherapeutics

12/01/2026 13:13

Jan 12 (Reuters) - Atara Biotherapeutics Inc ATRA.O:

PIERRE FABRE PHARMACEUTICALS: ON JAN 9, GOT COMPLETE RESPONSE LETTER FOR TABELECLEUCEL BLA FROM U.S. FDA

PIERRE FABRE: IN NEW CRL, FDA SAID IT NO LONGER CONSIDERS PREVIOUSLY ACCEPTED SINGLE-ARM ALLELE STUDY TO BE ENOUGH TO SUPPORT ACCELERATED APPROVAL

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