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Keeping Track: US FDA Approves Sanofi’s Dengvaxia, But Heron’s HTX-011 And Nabriva’s Contepo Fall Short

 
• 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 for the week in brief: The FDA’s Center for Biologics Evaluation and Research announced its third novel biologic approval of 2019 on 1 May, clearing dengue vaccine Dengvaxia on its first review cycle – but for only a slice of the population sought by Sanofi.

At the Center for Drug Evaluation and Research, new drug applications from Heron Therapeutics Inc. and Nabriva Therapeutics PLC did not fare so well, receiving complete response letters. Pediatric indications were granted for AbbVie Inc.’s Mavyret and Vertex Pharmaceuticals Inc.’s Kalydeco

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