The Priority Review

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Bayer HealthCare Pharmaceuticals Inc.

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  1. Approvals

    FDA approves Sunharbo for secondary stroke prevention

    The FDA approved Sunharbo (asundexian) 50 mg tablets on November 09, 2026 for adults at high risk of stroke after a mild-to-moderate non-cardioembolic ischemic stroke or high-risk TIA. The OCEANIC-STROKE phase 3 study enrolled 12,327 participants and found Sunharbo 50 mg once daily significantly reduced the risk of ischemic stroke by 26 % compared to placebo over a median treatment of 14.2 months.