FDA Commissioner Marty Makary has resigned, ending a turbulent tenure that included efforts to speed drug development and repeated controversy over agency management and scientific oversight. President Trump confirmed the departure and said Kyle Diamantas, previously deputy commissioner for food, will serve as acting commissioner. During Makary’s time at the agency, he supported initiatives aimed at accelerating reviews, including using AI in drug-development processes and shortening decision timelines by reducing “dead time.” The reporting also cited heightened internal turnover and analysts’ concerns that FDA predictability had become more uncertain. For biotech, the transition raises near-term questions about continuity of regulatory policies, especially those tied to review timelines, evidence standards, and internal governance—areas that can directly affect development strategy and trial planning.