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Bristol Signals Dapaglifozin’s Back On Track, Plans FDA Resubmission

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bristol suggests FDA has had a change of heart on the evolving filing package for diabetes drug dapagliflozin. Meanwhile, the company sees no additional U.S. regulatory hurdles ahead for the eagerly awaited, novel oral anticoagulant Eliquis.

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