Industry data show the FDA is on pace to approve its fewest new drugs and biologics since 2022, driven by lower application throughput and a tighter review calendar. Multiple companies await decisions on new molecular entities while overall agency approvals have slowed in 2025. Compounding the approval slowdown, a federal budget impasse and partial shutdown forced FDA layoffs and halted acceptance of new premarket filings requiring user fees. The agency flagged staffing gaps in surveillance and review functions and warned of delays to inspections and filings that could ripple through development timelines. The twin pressures—declining approval counts and operational disruption—create near‑term uncertainty for sponsors planning late‑stage filings and for patients awaiting new therapies.