Nature Biotechnology reports leadership turnover, staff cuts and new policies that reshaped the FDA’s 2025 approvals landscape, producing more follow-on products than first-in-class drugs. Separately, reporting flagged legal and procedural concerns around a new expedited approvals program, noting ambiguity over sign-off authority and skipped review steps for at least one product. The two pieces together document a regulatory agency in transition, raising practical questions about internal capacity, external oversight and legal risk for sponsors. Companies and investors should expect higher scrutiny and procedural shifts in 2026 filings and review strategies.