FDA: 2025 trends and 2026 outlook

30 December 2025

By Dr Nicola Davies

The US Food and Drug Administration (FDA) spent much of 2025 in the spotlight. Through steady drug approvals, renewed emphasis on transparency, and concrete steps to modernize its operations, the FDA’s actions this year helped shape expectations for 2026.

FDA activity in 2025 was shaped by four key themes:

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