The PD-1 inhibitor is the first immunotherapy approved for stage II and III MSI-H/dMMR locally advanced rectal cancer and may allow eligible patients to avoid chemotherapy, radiation, and surgery.
Commentary|Articles|December 19, 2025
The 5 Most Impactful FDA Approvals of 2025
Author(s)Laura Silvius, Managing Editor
The most impactful FDA approvals of 2025 feature groundbreaking treatments for mental health, STIs, diabetes, pain relief, and cardiovascular health.
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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.
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