MPR

Efgartigimod Alfa–Hyaluronidase Improves Ocular Myasthenia Gravis Symptoms

Results from ADAPT OCULUS are expected to support a sBLA submission to the FDA to secure a label expansion for oMG.
Nasdaq

Zai Lab : Efgartigimod Alfa Injection Approved In China For Generalized Myasthenia Gravis

(RTTNews) - Zai Lab Limited (ZLAB) and argenx (ARGX) announced that China's National Medical Products Administration or NMPA approved the Biologics License Application or BLA for efgartigimod alfa ...
Seeking Alpha

argenx Announces Positive CHMP Opinion for VYVGART (efgartigimod alfa) Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

VYVGART ® is first-and-only targeted IgG Fc-antibody fragment for CIDP First novel mechanism of action for CIDP treatment in more than 30 years CHMP positive opinion based on ADHERE data, the largest ...
Seeking Alpha

argenx Announces Approval of VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Japan for Generalized Myasthenia Gravis

Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that ...
Fox 5 San Diego

argenx and Zai Lab Announce Approval of VYVGART® (efgartigimod alfa injection) for Generalized Myasthenia Gravis in China

First-and-only approved FcRn antagonist for gMG patients by NMPA 68% of anti-AChR antibody positive gMG patients treated with VYVGART were responders (n=44/65) on the Myasthenia Gravis Activities of ...
Business Wire

Zai Lab Announces Acceptance of Supplemental Biologics License Application with Priority Review for Efgartigimod Alfa Injection (Subcutaneous Injection) in Chronic Inflammatory ...

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration ...
KXAN

Halozyme Announces argenx Received Positive CHMP Opinion for VYVGART® (efgartigimod alfa) Subcutaneous Injection with ENHANZE® for Chronic Inflammatory Demyelinating ...

SAN DIEGO, April 28, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that argenx received a positive opinion from the Committee for Medicinal Products for ...