FDA leadership upheavals, including the departure of Vinay Prasad from Center for Biologics Evaluation and Research (CBER), have stirred notable market reactions. Analysts anticipate benefits for Sarepta and cell and gene therapy developers following Prasad’s exit, considering his conservative regulatory stance and controversial decisions affecting therapies like Elevidys. These personnel shifts underline ongoing tensions between regulatory caution and industry innovation, contributing to uncertainty but also potential recalibration in biotech policy and approvals.