Fortress Biotech Inc., of New York, said the FDA granted subsidiary Cellvation Inc.'s CEVA-101 (autologous bone marrow-derived stem cells) regenerative medicine advanced therapy (RMAT) designation for the treatment of traumatic brain injury (TBI). Under terms of RMAT, the FDA will help facilitate the program's expedited development and review and provide guidance on generating the evidence needed to support approval of CEVA-101 for TBI. CEVA-101 is being assessed in phase II trials for severe TBI in children.