Friday, December 01, 2017 2:55:10 AM
S.FDA.
Nov.8 , 2017- Fortress Biotech today announced that the U.S.FDA has granded Cellvation's CEVA101 RMAT Designation for the Treatment of traumatic Brain injury.
Oktober 02, 2017 "Asterias Announces Two Significant Developments for Spinal Cord Injury Program.
"Also, the FDA granted the compagny's request for AST-OPC1 to be designated a RMAT under the 21st Century Cures Act.
So i found 11 granted: Humacyte, Enzyvant, jCyte , Vericel, Kias (Apr. 17, 2017), Bluebird, Juno Therapeutics, Athersys, Mallincrodt, Fortress Bio and Asterias Biotherapeutics.
See also article from nov. 27, 2017: FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies.
"In September, FDA disclosed that it already had 550 active investigational new drug applications (INDs) related to gene therapies, including 76 active INDs related to CAR-T cellular therapies. As of November 9, it has been reported that a total of 11 RMAT designations have been granted out of 31 requests.
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