In an unexpected development, Dr. Vinay Prasad has resumed leadership of the FDA’s Center for Biologics Evaluation and Research (CBER) shortly after stepping down. The Department of Health and Human Services confirmed that Prasad’s return at the FDA’s request follows tensions surrounding gene therapy regulation and external political criticism. His reinstatement underscores the ongoing pivotal role he plays in oversight of vaccines, gene therapy, and blood product regulation, during a period marked by heightened scrutiny of biologics and accelerated biotech innovation.