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Keeping Track: Some Calm Before The Storm

 
• By Michael Cipriano and Derrick Gingery

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

Keeping Track Feature image

Here's your news in brief: After the US FDA delivered a massive wave of approvals around the Thanksgiving holiday, the first week of December appeared to be a period of calm before the upcoming year-end storm.

The agency didn't approve any of the at least four remaining novel products in its 2018 review pipeline, although it...

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US FDA’s July AdComms: Pediatric Vaccine Safety, Blenrep’s Return, (Maybe) Capricor’s Cell Therapy

 
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More from Pink Sheet

US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
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Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

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Elevidys Helps Sarepta To First US FDA Platform Technology Designation

 
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Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.