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FDA Approves First-in-Class Bayer Drug for Reducing the Risk of Stroke - MedCity News

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FDA approves Bayer's asundexian as first-in-class factor XIa inhibitor for stroke prevention

The FDA approved asundexian (Sunharbo), a novel blood thinner from Bayer, to reduce the risk of recurrent stroke in adults, marking the first approval in the factor XIa inhibitor class.

Nov 9, 2026·6 sourcesDrug Policy, Pricing & ApprovalPharmaceutical IndustryDrug safetyCardiovascular diseasesClinical trialsFDA drug approvalDrug pricingAnticoagulants
FDA approves Bayer's asundexian as first-in-class factor XIa inhibitor for stroke prevention
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US FDA approves Bayer's blood thinner to prevent repeat strokes | Reuters

Medscape

FDA Approves First-in-Class Asundexian for Stroke Prevention