Vinay Prasad abruptly departed his role as Director of the FDA’s Center for Biologics Evaluation and Research after a brief and contentious tenure marked by stringent regulatory decisions, including the temporary hold on Sarepta Therapeutics' gene therapy Elevidys for Duchenne muscular dystrophy. The agency backtracked on the hold following political and patient advocacy pressures, fueling debate about regulatory oversight of gene therapies. Prasad's exit, reportedly influenced by political forces within the Trump administration and federal health leadership, has provoked mixed reactions across the biotech industry and raised questions on future FDA policy direction. His temporary successor is George Tidmarsh, FDA's Center for Drug Evaluation and Research director, who will assume acting leadership of CBER during this period of transition.