Diabetes pill by AstraZeneca, Bristol faces 3-month regulatory delay

10/26/2011 | Reuters

The FDA postponed until Jan. 28 a decision on whether to authorize AstraZeneca and Bristol-Myers Squibb's dapagliflozin as a once-daily treatment for adults with type 2 diabetes. In July, an advisory committee recommended against approval because of safety concerns. The drugmakers said they submitted additional late-stage trial data as requested by the agency.

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