The abrupt departure of Dr. Vinay Prasad, former head of the FDA's Center for Biologics Evaluation and Research (CBER), has spurred significant market reactions and raised questions about the agency's direction. Prasad's tenure was marked by contentious regulatory decisions, notably a hold and subsequent reversal on Sarepta Therapeutics' gene therapy Elevidys for Duchenne muscular dystrophy. His exit followed political pressures and disagreement within the FDA hierarchy. The FDA has named George Tidmarsh, CDER's director, as acting head of the biologics center. The Sarepta saga continues with partial resumption of Elevidys shipments for ambulatory patients after a fatality investigation deemed unrelated to treatment. Industry analysts express concern about the increasing politicization of FDA leadership and regulatory decisions.