The FDA AdComm Reboot: Part 2; Lessons from the Meeting on Replimune’s RP1 August 7, 2026 By Gayatri R. Rao —

https://www.thefdalawblog.com/2026/08/the-fda-adcomm-reboot-part-2-lessons-from-the-meeting-on-replimunes-rp1/?utm_source=rss&utm_medium=rss&utm_campaign=the-fda-adcomm-reboot-part-2-lessons-from-the-meeting-on-replimunes-rp1 The FDA AdComm Reboot: Part 2; Lessons from the Meeting on Replimune’s RP1 By Gayatri R. Rao — The day after CBER’s Cellular, Tissue, and Gene Therapies Advisory Committee meeting on Capricor Inc.’s Deramiocel for the treatment of cardiomyopathy in DMD, the Advisory Committee met on July 30, 2026, to discuss Replimune’s BLA resubmission seeking accelerated approval of RP1 (vusolimogene oderparepvec) in combination with nivolumab for advanced melanoma after progression on anti-PD-1 therapy.