Acer To Respond To Edsivo CRL In Ehlers-Danlos Syndrome
Executive Summary
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.
You may also be interested in...
Finance Watch: Genmab Launches This Year's Biggest Biopharma IPO In The US
Public Company Edition: Genmab raised $505.9m while other 17 July IPOs from Fulcrum and Mirum grossed $72m and $75m, respectively. Also, Horizon sells notes to pay down debt and Inovio reduces its workforce by 28%.
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.
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.