Atara says FDA accepts resubmitted Tab-cel BLA, sets March 31, 2027 PDUFA date
Bitget2026/10/14 12:05- 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.
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