Posted by Michael Wonder on 13 Nov 2017
Fortress Biotech announces Cellvation's CEVA101 granted FDA regenerative medicine advanced therapy designation for the treatment of traumatic brain injury
8 November 2017 - CEVA101 is being developed in partnership with The University of Texas Health Science Center at Houston.
Fortress Biotech today announced that the U.S. FDA has granted Cellvation’s CEVA101 (autologous bone marrow-derived stem cells) Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of traumatic brain injury (TBI).
Under terms of the RMAT designation, the FDA will help facilitate the program’s expedited development and review, and will provide guidance on generating the evidence needed to support approval of CEVA101 for TBI. CEVA101 is currently being assessed in Phase 2 clinical trials for severe TBI in children and adults.
