1. A Storm at the Helm: Leadership Shakeups In early August 2025, Dr. Vinay Prasad—director of the FDA’s Center for Biologics Evaluation and Research (CBER)—resigned following fierce pressure from conservative activists and biotech critics. The controversy stemmed from his decision to halt delivery of Sarepta Therapeutics’ gene therapy Elevidys, meant to treat Duchenne muscular dystrophy,...