Nature Biotechnology reviewed 2025 and documented leadership turnover, staff reductions, and policy changes at the FDA that complicated the agency’s review and approval operations. The piece cataloged impacts on approval cadences, noting an uptick in follow‑on product approvals relative to first‑in‑class drugs amid internal disruption. The report detailed new guidance, procedural adjustments, and reluctance among senior leaders to sign certain expedited program decisions, raising industry concerns about regulatory predictability. Companies and advisers are recalibrating interactions and timelines while monitoring how staffing and policy changes affect pre‑approval meetings and review cycles. The coverage signals a near‑term period of uncertainty for sponsors planning filings and for investors who price pipeline milestones against regulator responsiveness.