Hylton V. Joffe

Director of the Office of Cardiology, Hematology, Endocrinology, and Nephrology, FDA Center for Drug Evaluation and Research

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Last updated Nov 10, 2026

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FDA approves first Factor XIa blood thinner for repeat strokes

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Announced the approval

Roughly a quarter of the 795,000 Americans who have a stroke each year have had one before. On Monday the Food and Drug Administration approved Sunharbo, a daily pill from Bayer that cuts the risk of a second ischemic stroke by 26% when taken alongside existing antiplatelet therapy.

Updated 2 hours ago