Nature Biotechnology reported that 2025 at the FDA was marked by leadership turnover, staff reductions and policy shifts that reshaped the agency’s review environment while new drug approvals skewed toward follow‑on products rather than novel first‑in‑class agents. The analysis cites internal changes and a raft of procedural updates that contributed to an unsettled regulatory backdrop. The piece details how agency staffing and new guidance influenced review tempos and industry expectations, with implications for sponsor strategies around labeling, advisory committee pathways and accelerated programs. It also notes that some sponsors responded by prioritizing robust evidence packages and earlier regulatory engagement. Biotech executives and investors should interpret the report as a signal to factor regulatory execution risk into 2026 development planning and capital raising, with heightened emphasis on regulatory affairs resourcing and contingency plans.