The FDA has placed Nicole Verdun, MD, former super office director of the Office of Therapeutic Products at CBER, and her deputy Rachael Anatol, PhD, on administrative leave, stirring concerns across the biotech sector. Verdun had earned accolades for expediting bespoke CRISPR-based in vivo gene editing therapy developments, including the landmark treatment for a rare urea cycle disorder patient, Baby KJ. The upheaval follows recent leadership turbulence at FDA’s CBER, with director transitions and disputes affecting agency stability. Market reactions reflected moderate declines in cell and gene therapy stocks amid fears of regulatory uncertainty and loss of experienced oversight.