The FDA AdComm Reboot: Part 1; Lessons from the Meeting on Capricor’s Deramiocel August 5, 2026 By Gayatri R. Rao —

https://www.thefdalawblog.com/2026/08/the-fda-adcomm-reboot-part-1-lessons-from-the-meeting-on-capricors-deramiocel/?utm_source=rss&utm_medium=rss&utm_campaign=the-fda-adcomm-reboot-part-1-lessons-from-the-meeting-on-capricors-deramiocel After more than a year with nary an adcomm (just 2 drug approval-related meetings in the Makary era), CBER’s Cellular, Tissue, and Gene Therapies Advisory Committee meetings came back with a vengeance last week with back-to-back meetings to discuss two seemingly controversial cell and gene therapies that received complete response letters (CRLs) and are now under review following BLA resubmissions: Capricor’s Deramiocel for DMD and Replimune’s RP1 for advanced melanoma.