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Amgen's Prolia draws second complete response letter

This article was originally published in Scrip

Executive Summary

The US FDA has issued Amgen with a complete response letter for Prolia (denosumab) asking for further safety data for the first-in-class RANK ligand inhibitor in the treatment of cancer therapy induced bone loss. Only days earlier, the agency also denied approval for the antibody therapy for the treatment and prevention of osteoporosis.

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