The U.S. Food and Drug Administration selected the first nine recipients of its Commissioner’s National Priority Voucher pilot program, a move creating a path for dramatically shortened review timelines for products labeled national priorities. The cohort mixes investigational drugs, products already approved abroad and generics; included programs such as Disc Medicine’s NDA for bitopertin and Regeneron’s DB‑OTO gene therapy among others. Market response was immediate: Disc’s shares jumped after the list publication because inclusion could enable a regulatory decision this year. The pilot is intended to accelerate access for therapies addressing unmet needs — companies and investors now face tight timelines to align clinical, manufacturing and submission activities if they want to capitalize on the one‑to‑two month review window.