The recent resignation of Vinay Prasad, head of the FDA's Center for Biologics Evaluation and Research, has sent shockwaves across the biotech industry. Prasad's tenure was marked by controversial regulatory decisions, including a hold on Sarepta Therapeutics' gene therapy Elevidys, later partially reversed. His ouster follows pressure from political and industry groups and raises questions about the FDA's future direction, especially concerning vaccine and gene therapy approvals. Meanwhile, George Tidmarsh has been appointed acting head, signaling a potential shift in regulatory approaches. The biotech sector watches closely for policy changes and implications for drug approvals and market access.