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Keeping Track: Another Gene Therapy Approval, Several Priority Review Designations, And Many Resubmissions

 
• By Michael Cipriano and Sue Sutter

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

Keeping Track Feature image

Here's your news in brief: Gene therapies are continuing to make their way onto the scene, with Kite Pharma Inc.'s chimeric antigen receptor T-cell (CAR-T) therapy Yescarta (axicabtagene ciloleucel) becoming the second gene therapy to win a US FDA approval.

Pacira Pharmaceuticals Inc.and Charleston Laboratories Inc. are both working their way back from complete response letters (CRLs) for...

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