US FDA Approval Actions To Watch Out For In June
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.
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Keeping Track: US FDA Closes Out First Half Of 2019 With CRL For Edsivo, But A Burst Of Supplemental Approvals
The latest drug development news and highlights from our US FDA Performance Tracker.
Although the US FDA is looking for another clinical trial of Acer Therapeutics’ potential therapy for vascular Ehlers-Danlos syndrome, there may be further discussion about the route to market in this rare condition.
Antibacterials have been part of Merck's mission for decades, despite the market challenges, and it's expecting two new approvals this year. Infectious disease VP Joan Butterton talks about tackling those challenges and incentives that may help the industry address antimicrobial resistance.