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Keeping Track: A Good Week For Biologics And Probuphine, Less So For Eteplirsen And ZS-9

 
• By Bridget Silverman

The latest drug development news and highlights from our FDA Performance Tracker.

Biologics took center stage at FDA last week. The Center for Drug Evaluation and Research accepted another biosimilar application, while the Center for Biologics Evaluation and Research approved a novel agent – CSL Behring's Afstyla – and extended the age range and number of strains covered by the first cell culture flu vaccine.

FDA also approved Titan Pharmaceuticals Inc. and Braeburn Pharmaceuticals SPRL's Probuphine, a new implantable formulation of the partial...

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More from United States

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• By Sarah Karlin-Smith

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• By Jessica Merrill

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• By Leslie Small

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August Brings Fresh Faces And Tough Calls To US FDA User Fee Calendar

 
• By Bridget Silverman

The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.

More from North America

Court Allows MSN Marketing Of Entresto Generic, But More Legal Issues Pending

 
• By Dean Rudge

Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.

Generic Drugs And AI: Maximum Daily Dose Tool Could Help US FDA Be ‘At The Forefront’

 
• By Michael McCaughan

The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.

Will US FDA’s Leadership Rediscover The Value Of Advisory Committees?

 
• By Michael McCaughan

After the abrupt departure of CBER’s director, it seems FDA, and Vinay Prasad in particular, would likely have been well served by hearing from an advisory committee before requesting the suspension in sales of Sarepta’s DMD gene therapy Elevidys.