FDA approved three NMEs in June

June was another slow month for new molecular entity (NME) approvals at FDA, with two mAbs and a small molecule making it through review at the Center for Drug Evaluation and Research (CDER).

With an additional three approvals so far in July, the 2025 total for NMEs now stands at 19. While nearly a third of that total came in just four weeks, it still trails the 22 approvals recorded by mid-July last year and 26 over the same period in 2022...