Keeping Track: US FDA Clears Esperion’s Nexletol, Baudax’ Anjeso, Agile’s Twirla
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
You may also be interested in...
Office of New Drugs grants company’s appeal of complete response letter for tenapanor in dialysis patients, marking a rare sponsor victory through the agency’s formal dispute resolution process; new drug application resubmission is targeted for first half of 2023.
Ardelyx will add to FDA’s growing dispute resolution queue with plan to appeal tenapanor complete response letter; Avenue Therapeutics’ IV tramadol dispute resolution tops out with FDA plea for advisory committee advice.
Public Company Edition: Legend Biotech raised $424m in its US public market debut. Also, Pfizer commits up to $500m for equity investments and Allogene capitalizes on ASCO with a $550m offering.