Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, will leave the agency at the end of April. His departure was confirmed by FDA spokesman and Commissioner Marty Makary on Platform X. Prasad came to the FDA on a one-year sabbatical from the University of California, San Francisco. He implemented four major reforms: a requirement for one major trial instead of two, a national priority review program, a risk convergence framework for COVID-19 vaccines, and a new framework for ultra-rare diseases. He was previously briefly recalled in the summer of 2025 following a dispute over Sarepta Therapeutics' Elevidys gene therapy for Duchenne muscular dystrophy. More recently, the FDA under his leadership rejected applications to approve therapies for rare diseases, including uniQure's gene therapy for Huntington's disease, and refused to review Moderna's application for an mRNA flu vaccine, which was later withdrawn. Commissioner Makary stated that a successor would be appointed before his departure.[1][2][3]