FDA Approves First Factor Xla Inhibitor to Help Prevent Stroke in Certain Adults at High Risk

U.S. FDA — FDA today approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa (FXIa) inhibitor for use in combination with antiplatelet therapy to reduce the risk of stroke in adults following a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack.

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Auto-published by the finit.news Events monitor from U.S. FDA; summarized by AI and may contain errors — verify against the primary source. November 9, 2026.

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