Acer To Respond To Edsivo CRL In Ehlers-Danlos Syndrome
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.
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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.
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.