The FDA said it will be reshaping leadership after Commissioner Marty Makary resigned, with Kyle Diamantas stepping in as acting commissioner. The transition follows a tumultuous period for biotech, where multiple top positions were filled on an interim basis and senior turnover left companies watching whether Makary’s drug-review reforms would persist. Biotech stakeholders cited uncertainty around how review timelines and guidance will evolve under new leadership, particularly as acting officials face time-limited authority. Multiple regulatory staff changes over recent months have also raised concern about consistency in agency decision-making and scientific depth. The leadership shift lands as the industry remains focused on regulatory predictability—especially for novel modalities such as gene therapies, rare disease treatments, and expedited review pathways—where small changes in policy or process can materially alter development timelines.