The FDA accepted the resubmitted NDA for palovarotene after Ipsen provided the additional clinical data that was requested. A PDUFA date was set for 8/16/2023.
The FDA rejected the combination of foscarbidopa and foslevodopa for the treatment of motor fluctuations in patients with advanced Parkinson's disease and requested additional information about the pump used to administer the drugs.
Stay informed, subscribe to the
Prescribe Right Pharmaceutical Pipeline Tracker
Latest Tweets from Prescribe Right