FDA Cellular, Tissue, and Gene Therapies Advisory Committee

Rule Changes

Voted 10-3 on July 30 that RP1's trial data were evaluable, a recommendation the FDA followed six days later.

The FDA granted accelerated approval on August 6 to Replimune's tumor-injected virus therapy, now sold as Tudriqev, after rejecting it twice. An advisory panel had voted 10-3 on July 30 that the trial data were reliable enough to support approval, despite FDA staff's earlier doubts.

Updated Aug 8