Marty Makary resigned as FDA commissioner, ending a politically turbulent tenure as Kyle Diamantas, previously the agency’s top food regulator, moved in as acting commissioner. The transition follows reported turmoil inside the agency and further heightens uncertainty for biotech leaders watching review timelines and regulatory guidance stability. Biotech stakeholders have pointed to a mix of initiatives under Makary, including drug-approval reforms intended to speed development and incorporate AI, alongside criticism tied to leadership turnover, alleged guidance shifts, and delayed reviews. Observers said acting leadership will face tight timelines for nominations and confirmation. The change adds another leadership inflection point for FDA-managed programs that biotech teams rely on for clinical-trial design, endpoints, and accelerated pathways. For the sector, the immediate focus shifts to whether Diamantas’ interim stewardship will preserve existing frameworks or introduce new review prioritization and policy direction.