Vinay Prasad will leave the FDA at the end of April, marking a second departure after a tenure marked by high-profile reversals and industry clashes. Multiple outlets reported the move; STAT and other outlets detailed controversies tied to vaccine and gene-therapy review decisions under Prasad’s leadership. The resignation follows public disputes over review pathways for Moderna’s flu shot and demands for additional trials on rare-disease therapies. The exit leaves the Center for Biologics Evaluation and Research (CBER) leadership in flux and raises immediate questions about ongoing reviews of vaccines, cell and gene therapies.
Get the Daily Brief