Commentary|Articles|December 19, 2025

The 5 Most Impactful FDA Approvals of 2025

The most impactful FDA approvals of 2025 feature groundbreaking treatments for mental health, STIs, diabetes, pain relief, and cardiovascular health.

The FDA spent 2025 challenging norms. Some of these norms, such as vaccination standards and schedules and responses to 2 measles outbreaks, proved controversial; others, such as their approval of breakthrough therapies and innovative medical devices, may have a long-lasting positive impact on Americans for years to come. These 5 approvals stand up for their clinical significance, potential impact on public health, or the novel modalities they introduced to Americans for the first time.