Brief: Pierre Fabre Pharmaceuticals On Jan 9, Got Complete Response Letter For Tabelecleucel BLA From U.S. FDA
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 Source text: ID:nPn86TQCza Further company coverage: ATRA.O ((Reuters.Briefs@thomsonreuters.com;))
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