The abrupt departure of Vinayak Prasad as director of the FDA’s Center for Biologics Evaluation and Research (CBER) has drawn industry attention. Prasad, who assumed the post in May 2024, was noted for a conservative stance on gene therapy approvals, including public criticism of Sarepta Therapeutics' Duchenne muscular dystrophy gene therapy Elevidys. Analysts suggest his exit may benefit cell and gene therapy developers. Internal FDA discord and leadership turmoil have also influenced regulatory decisions, underscoring ongoing uncertainty in therapeutic approvals within the biotech sector.