Vinay Prasad has unexpectedly rejoined the FDA to lead the Center for Biologics Evaluation and Research (CBER), weeks after stepping down amid tensions surrounding gene therapy regulation and public criticism. The return, confirmed by HHS, follows his abrupt departure triggered by controversies over Duchenne muscular dystrophy gene therapy governance. Prasad’s reinstatement underscores ongoing challenges in biotherapeutics oversight and agency leadership continuity.