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Keeping Track: Delay (For Celgene), Delay (For Allergan), Goose! (Approval For Lilly)

 
• By Michael Cipriano and Bridget Silverman

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

Keeping Track Feature image

Here's your news in brief from the land of reviews and approvals: Celgene Corp. has suffered yet another setback, as the US FDA has refused to file a new drug application (NDA) for its multiple sclerosis drug ozanimod.

The agency also pushed back the Prescription Drug User Fee Action (PDUFA) date for Allergan PLC's ulipristal acetate NDA, requesting more time to evaluate the findings

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