WASHINGTON — The United States Food and Drug Administration (FDA) on Monday, 9 November 2026, approved Bayer's asundexian, sold under the brand name Sunharbo, as a once-daily 50 mg tablet to help prevent repeat strokes in adults who have recently had a mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA), often called a "mini-stroke." The decision makes Sunharbo the first Factor XIa inhibitor ever approved in the United States, and the first drug with a new mechanism of action for this use in years. It is designed to be taken alongside antiplatelet therapy, not instead of it, and it is not approved to prevent strokes in people with atrial fibrillation. Illustration: A doctor holding a bottle of Sunharbo tablets beside a stylised blood vessel. This is an AI-generated illustration, not a photograph of a real person, product or event. What Happened The FDA announced the approval on Monday, 9 November 2026, clearing Sunharbo fo...