PIERRE FABRE PHARMACEUTICALS STATEMENT REGARDING RECEIPT OF COMPLETE RESPONSE LETTER FOR TABELECLEUCEL BIOLOGICS LICENSE APPLICATION FROM THE U.S. FOOD AND DRUG ADMINISTRATION
PR Newswire —
SECAUCUS, N.J., Jan. 12, 2026 /PRNewswire/ -- On January 9, 2026, Pierre Fabre Pharmaceuticals, Inc. received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) stating that the Agency is unable to approve the tabelecleucel Biologics License Application...