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If everything is in order, they accept it for filing and assign a PDUFA date

Li, Q., He, M., Zhou, F., Ye, F

Additionally, a high percentage of participants achieved a weight reduction of 5% or more (85% with 5 mg, 89% with 10 mg, and 91% with 15 mg of tirzepatide)

The cag + tirz combination covers three pathways instead of two, but it has no human trial data of its own

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FDA approval normally follows a formal application supported by adequate evidence for a defined product, dose, route, patient population, manufacturing process, labeling, effectiveness, and safety profile