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Keeping Track: Intercept Submits OCA For NASH; Zogenix’ Fintepla Returns; US FDA Approves Bavarian Nordic Vaccine

 
• By Bridget Silverman

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

Keeping Track Feature image

Here's your US review and approval news in brief for the week: The bruising battle to produce a treatment for nonalcoholic steatohepatitis produced its first new drug application with Intercept Pharmaceuticals Inc.’s submission of obetacholic acid. With the expected priority review for the breakthrough-designated drug in NASH, Intercept could see FDA action in March 2020.

The Intercept announcement capped a busy week for submissions. Zogenix Inc. returned to FDA with a resubmitted NDA for Fintepla, its breakthrough-designated treatment for Dravet syndrome, after a refuse-to-file...

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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

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