The recent departure of Vinay Prasad as director of the FDA's Center for Biologics Evaluation and Research (CBER) marks a significant turning point in regulatory oversight of gene therapies. Prasad's tenure was characterized by conservative approaches to drug approvals, notably his opposition to Sarepta Therapeutics' Duchenne muscular dystrophy gene therapy Elevidys and the complete response letter issued to Replimune's melanoma drug. Insider reports reveal that FDA Oncology Center of Excellence director Richard Pazdur played a key role in rejecting Replimune's RP1 therapy, overriding consensus from other agency staff. These developments reflect internal challenges within the FDA and impact the landscape of cell and gene therapy approvals.