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Argenx Announces U.S. Food and Drug Administration (FDA) Approval of VYVGART™ (efgartigimod alfa-fcab) in Generalized Myasthenia Gravis
VYVGART is the first-and-only FDA-approved neonatal Fc receptor blocker 68% of anti-acetylcholine receptor (AChR) antibody positive gMG patients treated with VYVGART were responders (n=44/65)
Submissions to Seek Approval in both ERT Naïve and ERT Switch Pompe Patients Completion of Rolling Biologics License Application On-Track by end of 2Q21 PHILADELPHIA, May 03, 2021 (GLOBE NEWSWIRE) -- Amicus Therapeutics (NASDAQ:FOLD) today announced the completion of a successful Type B Pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA) for AT-GAA (cipaglucosidase alfa co-administered with miglustat), its investigational two-component therapy for the treatment of Pompe disease. Based on this formal pre-BLA meeting and the final written communi...