Posted by Michael Wonder on 14 Jan 2026
argenx announces FDA acceptance of supplemental biologics license application with priority review for Vyvgart in AChR-Ab seronegative gMG
13 January 2026 - argenx today announced that the US FDA has accepted for priority review a supplemental biologics license application for Vyvgart (IV: efgartigimod alfa-fcab) for the treatment of adults with acetylcholine receptor antibody seronegative generalised myasthenia gravis.
The application has been granted a PDUFA target action date of 10 May 2026.
