The FDA approved three new molecular entities (NMEs) in June 2025, contributing to a total of 19 approvals so far this year, signaling continued drug pipeline activity. Concurrently, Commissioner Marty Makary initiated negotiations for the next generic drug user fee agreement, emphasizing generics’ role in healthcare affordability. Additionally, he proposed fast-review vouchers conditional on drugmakers lowering U.S. drug prices, a novel regulatory incentive to address costs.