Tabelecleucel shows promising efficacy in treating EBV-positive PTLD, offering hope for patients resistant to previous ...

The CRL was solely related to observations as part of a standard pre-license inspection of a third-party manufacturing facility for EBVALLO. The CRL did not identify any deficiencies related to ...

In January 2025, the EBVALLO™ (tabelecleucel) program was placed on clinical hold. The clinical hold was directly linked to GMP compliance issues identified during the pre-license inspection of ...

The revision follows concerns related to the delayed approval of Atara's Ebvallo and the possibility that the company may discontinue its CAR-T development in the first quarter of 2025.

“We will further narrow our focus on the future financial value of EBVALLO for the benefit of all stakeholders. Atara continues to productively engage with our partner Pierre Fabre Laboratories ...

The award was presented to Pierre Fabre Laboratories, Atara’s global development and commercialization partner for Ebvallo. The Prix Galien International Awards for Life Science Research is ...

Atara has just announced a CRL by FDA for EBVALLO. EBVALLO is already approved in Europe since December 2022 and the cause of the CRL seems minor and easily addressable. The CRL has a major impact ...

Preceding the sharp decline was the Food and Drug Administration releasing a letter to the company stating concerns about the third-party manufacturer of its blood cancer drug Ebvallo and delaying ...

Atara is working closely with its partners and the FDA to lift clinical hold and support EBVALLO™ BLA resubmission in the U.S. Atara remains focused on delivering on the future financial value ...