FDA approvals in June included Tregzi (Orca-T), described as the first approved allogeneic Treg-based cell therapy. The product is designed as a precisely composed regulatory T-cell graft intended to rebuild the patient’s blood and immune system after a matched-donor hematopoietic stem cell transplant and limit graft-versus-host disease reactions. The therapy is used with a myeloablative preparative regimen and is positioned to improve chronic GVHD-free survival, introducing a new cell-therapy modality for hematologic malignancy patients receiving transplant procedures. As a regulatory milestone, the approval expands the FDA’s framework for advanced allogeneic immune-cell approaches beyond autologous platforms and into more standardized donor-cell manufacturing.