The U.S. FDA has undertaken significant leadership realignments within the Center for Biologics Evaluation and Research, including the removal of senior executives to align management with aggressive goals for rare disease therapeutics. Concurrently, the FDA Commissioner unveiled a pilot national priority voucher program designed to expedite drug reviews by one to two months, aiming to enhance competitiveness in early-stage biotech clinical trials. These actions underscore the agency’s commitment to speeding innovation and maintaining U.S. leadership amidst global regulatory challenges.