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US FDA Approval Actions To Watch Out For In June

 
• By Bridget Silverman

User fee goal date calendar for June includes AMAG’s female sexual dysfunction drug Vyleesi, new indications for Sanofi/Regeneron’s Dupixent in rhinosinusitis and Merck’s Zerbaxa in nosocomial pneumonia.

June-calendar

The US Food and Drug Administration has a dozen user fee goal dates for pending applications coming up in June, according to the Pink Sheet’s US FDA Performance Tracker.

The majority of the applications are for supplemental indications, but the June calendar also features two new molecular entities – AMAG Pharmaceuticals Inc.’s Vyleesi and Acer Therapeutics Inc.’s...

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