Tue, 22/11/2022 - 06:46
argenx Announces U.S. FDA Acceptance of Biologics License Application for Subcutaneous Efgartigimod in Generalized Myasthenia Gravis with Priority Review
Amsterdam, the Netherlands
argenx SE today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for SC efgartigimod (1000mg efgartigimod-PH20) for the treatment of adult patients with generalized myasthenia gravis (gMG). The application has been granted a Prescription Drug User Fee Act (PDUFA) target action date of March 20, 2023.
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