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Additionally, despite substantial weight loss, systematic cardiovascular outcomes trials have not been completed to establish whether GLP3 reduces major adverse cardiovascular events

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Tracy Beth Heg, MD, PhD, Acting Director of the FDAs Center for Drug Evaluation and Research, set out the significance in the agencys approval statement: The approval of orforglipron is another example of how the FDAs CNPV pilot program has been able to more quickly bring effective treatments to Americans

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