FDA’s June approvals included Orca-T (Tregzi), the first approved allogeneic Treg-based cell therapy in matched-donor hematopoietic stem cell transplantation for hematologic malignancies. The therapy uses purified regulatory T cells to rebuild immune function, preserve anti-cancer response, and reduce graft-versus-host disease (GVHD) risk when given with a myeloablative preparative regimen.