Keeping Track: Opdivo Dosing Simplified; Yosprala, Cuvitru Approved; Telotristat Review Lengthened
The latest drug development news and highlights from our FDA Performance Tracker.
You may also be interested in...
Keeping Track: Novartis' Ribociclib, Tesaro's Niraparib Submitted; Catalyst Clears Path For Firdapse Resubmission
In retrospect, the European Society for Medical Oncology meeting was a showcase for pivotal trial data included in a burst of targeted therapy new drug applications, and more drug development news and highlights from our FDA Performance Tracker.
Sponsor hopes to demonstrate that FDA's process for reviewing extended-release abuse-deterrent opioids may not be appropriate for an immediate-release product. Apadaz would be the first immediate-release opioid with an abuse-deterrent claim if approved.
Faced with two unsuccessful pivotal trials, FDA advisory committee concludes substantial evidence of a treatment effect in non-muscle invasive bladder cancer has not been demonstrated.