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

 
• By Michael Cipriano

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

FDA Advisory Committee Feature image

After cardiovascular safety issues led to a complete response letter (CRL) in 2017 for Amgen Inc.'s osteoporosis drug Evenity (romosozumab), the drugmaker is now hoping that its proposal for a narrower indication and a boxed warning will be sufficient to obtain a favorable US FDA advisory committee recommendation.

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‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
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More from Regulatory Trackers

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EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

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