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FDA gets request to approve Pradaxa reversal agent idarucizumab

Big news! Boehringer Ingelheim has submitted an application to the FDA requesting accelerated approval for idarucizumab, the reversal agent for Pradaxa (dabigatran). See: Boehringer Ingelheim Submits Biologics License Application to FDA for Idarucizumab*, Investigational Specific Reversal Agent for Pradaxa® Additionally, they have submitted for marketing approval by Health Canada and the European Medicines Agency (EMA). See: Boehringer …

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