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Keeping Track: US FDA Closes Out First Half Of 2019 With CRL For Edsivo, But A Burst Of Supplemental Approvals

 
• By Michael Cipriano and Bridget Silverman

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

Keeping Track Feature image

The US Food and Drug Administration's novel drug approval count will stand at 13 as the first half of 2019 comes to a close, as the agency issued a complete response letter for Acer Therapeutics Inc.'s Ehlers-Danlos syndrome (vEDS) candidate Edsivo (celiprolol).

But the FDA still burst through the June finish line with a string of supplemental approvals in the final week of the month. And the agency gave its blessing to Pfizer Inc

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