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Amgen's Evenity Faces CV Safety Gauntlet At US FDA Advisory Cmte.

Executive Summary

Narrower indication and a boxed warning for Amgen's osteoporosis drug romosozumab might be sufficient to permit approval.  

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Amgen's Evenity Clears US FDA With Preferred Indication, Black Box Warning

Osteoporosis treatment romosozumab-aqqg indicated for postmenopausal women at high risk for fracture; advisory committee appears to have help persuade FDA that a black box would be sufficient to manage cardiovascular risk rather than a narrower indication.

Evenity Likely Headed For Approval With Amgen's Proposed Indication, But Postmarketing Requirements Remain Unclear

US FDA advisory committee splits on whether Amgen's osteoporosis drug romosozumab needs observational study or randomized controlled trial to assess cardiovascular risks. 

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