Marty Makary resigned as FDA commissioner, with Kyle Diamantas stepping in as acting commissioner. The change ends a tenure that reshaped biotech expectations around drug review processes, including initiatives aimed at speeding development and adopting AI-assisted approaches, but also coincided with internal upheaval and disputes over guidance. Industry observers highlighted uncertainty created by leadership turnover and acting-role constraints on senior reviewers, raising questions about how quickly current reforms will persist. The abrupt transition is now forcing companies to re-evaluate timelines and engagement strategies with the agency. The immediate focus for biotech stakeholders is whether the next permanent FDA leadership will maintain Makary-era pathways—or alter course on review cadence, scientific depth and rare disease frameworks.