FDA reviving drugs derailed under Makary and Prasad

Momentum is building at FDA for putting medicines that were derailed under former FDA Commissioner Marty Makary back on track. Few FDA decisions appeared more final than the agency’s second rejection of vusolimogene oderparepvec (RP1) from Replimune. Its decision to reopen the application is the latest indication that previously closed regulatory cases are being reconsidered.

Since March, FDA has approved, revived or reopened regulatory pathways for at least seven therapies that had encountered major setbacks under Makary, including products that received complete response letters (CRLs) and applications that appeared effectively dead. Additional cases are under review...