Pierre Fabre Pharmaceuticals Inc. Announces FDA Acceptance and Priority Review of the Biologics License Application (BLA) for Tabelecleucel for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD)
Atara Biotherapeutics(US:ATRA) Prnewswire·2025-07-24 20:57First allogeneic T-Cell therapy BLA offers hope to EBV+ PTLD patients who have limited treatment options and lifespan measured in only a few weeks to months following failure of initial treatmentEBV+ PTLD is an ultra-rare, acute, and potentially deadly blood malignancy that occurs after hematopoietic cell transplant (HCT) or solid organ transplant (SOT) when T-cell activity is impaired by immunosuppressionTabelecleucel has a Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026 and w ...