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January 13, 2026

Atara receives FDA complete response letter for Ebvallo BLA application

Atara Biotherapeutics has announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the biologics licence application (BLA) of Ebvallo (tabelecleucel).

The first CRL identified a single GMP compliance deficiency, without concerns over trial design, efficacy, or safety. Credit: SmartPhotoLab / Shutterstock.com.