Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER), resigned unexpectedly after a tumultuous three-month tenure marked by controversial regulatory actions including the temporary hold and subsequent partial resumption of Sarepta Therapeutics’ gene therapy Elevidys for Duchenne muscular dystrophy (DMD). Prasad faced pressure from political figures and activist groups, leading to his ouster which stirred mixed reactions within biotech circles. His departure raises questions about the FDA’s future direction and regulatory tone, especially regarding rare disease treatments and vaccine policies. The FDA has appointed George Tidmarsh as acting director for CBER amidst ongoing uncertainty.