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Amgen's Denosumab: Quick Takes from FDA's Advisory Committee Meeting

This article was originally published in RPM Report

Executive Summary

FDA’s Reproductive Health Products Advisory Committee meeting on Amgen’s osteoporosis drug could have derailed denosumab’s prospects at a number of key turning points. But Amgen’s presentation combined with the drug’s effi cacy profi le pushed the investigational product through a key regulatory toll gate relatively unscathed.

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