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Boehringer Kept Pradaxa Analysis From FDA, Records Show
Boehringer Ingelheim GmbH didn’t disclose a data analysis to U.S. regulators that indicated the blood-thinner Pradaxa may have caused more fatal bleeding after it was cleared for sale than the drug did in a study used to win approval, unsealed court filings show.
Boehringer gave U.S. regulators one analysis of data gathered after the drug’s October 2010...
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