Argenx: FDA Accepts Priority Review sBLA for Vyvgart in Seronegative gMG
ReutersJan 13, 2026 6:03 AM
Jan 13 (Reuters) - argenx SE ARGX.BR:
ARGENX ANNOUNCES FDA ACCEPTANCE OF SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION WITH PRIORITY REVIEW FOR VYVGART IN ACHR-AB SERONEGATIVE GMG
APPLICATION HAS BEEN GRANTED A PRESCRIPTION DRUG USER FEE ACT (PDUFA) TARGET ACTION DATE OF MAY 10, 2026
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