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US-based Johnson & Johnson (NYSE: JNJ) has made a global first New Drug Application (NDA) filing with the US FDA for its FcRn blocker nipocalimab. The drug’s initial indication is anticipated to be for the treatment of adults with generalized myasthenia gravis (gMG) who test positive for certain antibodies. This…
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Argenx SE (NASDAQ: ARGX), the U.S. partner of China-based biopharmaceutical company Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), has announced that the U.S. Food and Drug Administration (FDA) has granted approval for VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).…