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News about "asundexian"
EMA Confirms Asundexian MAA for Assessment in Secondary Prevention of Ischemic Stroke
The EMA has accepted the Marketing Authorisation Application (MAA) for asundexian, the first Factor XIa (FXIa) inhibitor under review in Europe for secondary prevention of ischemic stroke. The submission is supported by positive phase 3 OCEANIC-STROKE data.
Asundexian | 11/06/2026 | By News Bureau | 110
Bayer Wins US FDA Priority Review for Asundexian Stroke Prevention Therapy
Bayer receives US Food and Drug Administration Priority Review (PR) for asundexian to reduce recurrent stroke risk after non-cardioembolic ischemic stroke or transient ischemic attack, supported by positive phase 3 OCEANIC-STROKE trial results.
Asundexian | 20/05/2026 | By News Bureau
China's CDE Grants Priority Review to Bayer's FXIa Inhibitor
China’s Center for Drug Evaluation (CDE) grants Priority Review (PR) to Bayer’s FXIa inhibitor, highlighting its potential clinical value in reducing stroke risk.
Asundexian | 08/05/2026 | By News Bureau
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