The recent abrupt departure of Vinay Prasad as head of the FDA’s Center for Biologics Evaluation and Research (CBER) has sparked industry-wide uncertainty. Prasad’s tenure was marked by a cautious stance on gene therapies and heightened regulatory scrutiny, exemplified by holds on Sarepta’s Elevidys gene therapy trials. His removal, reportedly influenced by political pressures, signals potential reshaping of FDA policies and regulatory approaches. The implications of these leadership changes have been widely debated in the biotech community, reflecting concerns over the balance between innovation and safety oversight.