Atara says FDA accepts resubmitted Tab — cel BLA, sets March 31, 2027 PDUFA date
FDA accepted the resubmitted BLA for tabelecleucel (Tab-cel) to treat EBV+ PTLD in patients aged 2 and older. Class 2 resubmission sets a PDUFA target action date of March 31, 2027. Partner Pierre Fabre Pharmaceuticals filed the resubmission; Atara could receive a USD 31 million milestone if Tab-cel is cleared. Disclai