Orca Bio’s Tregzi (an allogeneic, regulatory T cell–based approach) won U.S. approval to reduce transplant-related complications in patients with hematologic malignancies undergoing matched-donor allogeneic HSCT. The FDA’s decision follows the Precision-T phase III program and targets improvements in chronic graft-versus-host disease–free survival, moving Tregzi toward broader access via transplant centers and, potentially, the VA channel for eligible populations.