Posted by Michael Wonder on 07 Sep 2023
US FDA accepts marketing authorisation application for immunoglobulin Yimmugo
7 September 2023 - First marketing authorization application for a Biotest product from new "Biotest Next Level" production facility for the US.
Biotest AG announced today that the biologics license application for the polyspecific immunoglobulin preparation Yimmugo (IgG next generation) has been accepted for review by the US FDA after the 60 day validation phase.
