Pierre Fabre and Atara Biotherapeutics resubmitted Ebvallo (tabelecleucel) to the FDA after the agency rejected the cell therapy twice for EBV+ post-transplant lymphoproliferative disease. The latest filing comes after the FDA’s earlier positions shifted following changes in FDA leadership. The partners said their updated resubmission aligns with the regulator on a Class 2 BLA pathway, supported by additional data included in the submission. They also reported GMP compliance issues had been resolved and emphasized that the FDA’s clinical data critique differed from prior alignment about the adequacy of the single-arm Phase 3 ALLELE dataset. The case underscores how manufacturing readiness and trial interpretability remain central to FDA review decisions for complex autologous-style cellular products, even when safety concerns are not the primary driver.