Posted by Michael Wonder on 19 Jul 2024
Atara Biotherapeutics announces US FDA acceptance and priority review of the biologics license application for tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
17 July 2024 - PDUFA target action date of 15 January 2025.
Atara Biotherapeutics today announced that the US FDA has accepted the filing of its biologics license application for tabelecleucel indicated as monotherapy for treatment of adult and paediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease who have received at least one prior therapy.
