Posted by Michael Wonder on 29 Mar 2022
Gadopiclenol marketing authorisation dossier submissions accepted for review by EMA and FDA
29 March 2022 - Priority review granted by U.S. FDA.
Guerbet has recently submitted a new drug application to the U.S. FDA and a centralised application for marketing authorisation to the EMA for gadopiclenol, an investigational macrocyclic gadolinium-based contrast agent.
Those applications have been accepted for review by EMA and FDA on 24 February and 28 March respectively.
