The U.S. Food and Drug Administration (FDA) is undergoing significant shifts in leadership and procedural reforms aimed at accelerating drug approval timelines. Key cell and gene therapy leaders were removed amid broader agency restructuring. FDA Commissioner Martin Makary is spearheading initiatives to modernize regulatory processes, citing inefficiencies and prolonged timelines exceeding a decade for new drug approvals. A newly announced Commissioner’s National Priority Voucher program plans to expedite reviews to 1–2 months for drugs addressing U.S. national interests, including public health crises and innovation needs. This pilot program requires early submission of manufacturing information to enable parallel review workflows, supported by the integration of AI tools to prevent delays. These reforms seek to maintain U.S. leadership in biotechnology on the global stage while balancing oversight and efficiency.