The FDA declined to approve EBVALLO (tabelecleucel), Atara’s treatment for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) in patients who have received prior ...
Shares of Atara Biotherapeutics ATRA plunged 40.5% on Thursday after the FDA issued a complete response letter (CRL) against the company’s biologics license application (BLA) seeking approval of lead ...
・This is the second time that the FDA has refused to approve EBVALLO. ・Atara said in a statement on Monday that the FDA’s new position is “contrary” to its prior alignment with the company on the ...