Nature Biotechnology reported leadership changes, staff cuts and policy shifts at the US Food and Drug Administration that shadowed 2025 drug approvals, a year marked by fewer first‑in‑class authorizations and more follow‑on products. The analysis highlighted organizational disruptions and new review practices that affected approval timelines and internal willingness to sign off on expedited programs. The article and commentaries point to an agency in transition: changes in senior leadership, altered review procedures and staff capacity constraints could reshape the regulatory landscape for novel modalities and expedited pathways. Companies navigating late‑stage development should factor potential procedural variability into filing strategies and sponsor‑FDA engagement plans. Regulatory affairs teams will monitor how the FDA stabilizes processes and what operational changes mean for rolling submissions, advisory committees and post‑market commitments in 2026.