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Dapagliflozin Gains Strong FDA Panel Endorsement The Second Time Around

This article was originally published in The Pink Sheet Daily

Executive Summary

In 13-1 vote, advisory committee backs Bristol/AstraZeneca’s SGLT-2 inhibitor for type 2 diabetes, saying that residual concerns about cardiovascular safety and bladder cancer will be clarified with planned and ongoing post-marketing studies; approval recommendation follows a negative panel vote in 2011.

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