India, July 24 -- Atara Biotherapeutics Inc. (ATRA) is one step closer to securing approval for Tabelecleucel, a first-of-its-kind treatment for patients in the U.S.
Tabelecleucel, an innovative allogeneic T-cell immunotherapy, is proposed as monotherapy for the treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy.
The FDA has accepted Atara's Biologics License Application (BLA) for Tabelecleucel, with a regulatory decision anticipated on January 10, 2026. This is the company's second attempt to gain approval after its initial application was rejected in January of this year due to issues in...