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Amgen's Prolia gets complete response from US FDA for PMO

This article was originally published in Scrip

Executive Summary

The US FDA has hit Amgen with a complete response letter for its big hope, the bone drug Prolia (denosumab). While the agency has not requested more clinical studies for the postmenopausal osteoporosis (PMO) treatment indication, further trials are needed if it is to be approved as a preventative PMO therapy.

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