401: Makary’s departure and Cassidy’s tenuous Senate seat

FDA Commissioner Marty Makary has resigned following mounting political pressure regarding vaping regulations and the review process for the abortion drug mifepristone. Corporate attorney Kyle Diamantis has stepped in as acting commissioner, signaling a potential shift toward a more stable, process-oriented regulatory approach. Simultaneously, Louisiana Senator Bill Cassidy faces a precarious Republican primary, where his past political decisions have alienated key segments of the electorate, threatening his influence over future healthcare appointments and policy. In the biotech sector, Biogen’s tau-targeting Alzheimer’s drug failed its primary endpoint despite showing potential in low-dose cohorts, while Regenexx Bio has delayed its FDA filing for a Duchenne muscular dystrophy gene therapy due to ongoing regulatory uncertainty. These developments highlight the significant volatility within the FDA and the broader impact of political shifts on drug approval timelines and healthcare innovation.