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

 
• By Michael Cipriano

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

Amgen Inc.'s osteoporosis drug Evenity (romosozumab) is likely headed toward approval with the drugmaker's proposed indication following a favorable vote from the US FDA's Bone, Reproductive and Urologic Drugs Advisory Committee, although the type of postmarketing study the agency will require to assess cardiovascular risk remains unclear following disagreements among the panelists.

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AMR-Targeting Drug Secures EMA PRIME Designation

 
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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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US FDA’s March Approval Candidates Take Aim At Established Markets

 
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March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.

More from Regulatory Trackers

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

 
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Global Pharma Guidance Tracker – February 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

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