Posted by Michael Wonder on 13 May 2022
Update on U.S. FDA review of biologics license application for bimekizumab
13 May 2022 - UCB announced today that the U.S. FDA has issued a complete response letter regarding the biologics license application for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis.
The complete response letter states that certain pre-approval inspection observations must be resolved before approval of the application.
