ARTICLE | Regulation
Upcoming FDA adcomms will test post-Makary independence
Replimune and Capricor meetings revisit Prasad-era controversies, while peptide review will test MAHA’s influence over FDA
June 26, 2026 9:39 PM UTC
In another sign that FDA is reverting to a more conventional approach to regulation, the agency will hold two advisory committee meetings in July to consider high-profile, controversial approval decisions.
One will center on RP1 vusolimogene oderparepvec from Replimune Group Inc. (NASDAQ:REPL) to treat advanced melanoma. Another will focus on a BLA from Capricor Therapeutics Inc. (NASDAQ:CAPR) for deramiocel (CAP-1002), an allogeneic cardiac-derived cell therapy for cardiomyopathy associated with Duchenne muscular dystrophy (DMD). ...