The evolving regulatory landscape and executive movements shape biotech’s strategic prospects. BioCentury reports FDA commissioner Marty Makary's controversial intervention attempt in KalVista’s drug review, raising governance concerns. The FDA is undertaking landmark reviews to clarify rare disease policies, testing commitment to biomarker-based accelerated approvals. Management updates include Danaher’s appointment of AI expert Martin Stumpe as chief technology officer, and Qiagen’s selection of Stephen Rusckowski as supervisory board chairman. These developments reflect ongoing shifts in regulatory oversight and leadership critical for industry trajectory.