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Myasthenia Gravis News

FDA Approves Imaavy (nipocalimab-aahu) for the Treatment of Generalized Myasthenia Gravis (gMG)

SPRING HOUSE, Pa., (April 30, 2025) – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved Imaavy (nipocalimab-aahu), a human FcRn-blocking m...

FDA Approves Self-Injection of Vyvgart Hytrulo

WEDNESDAY, April 16, 2025 – The U.S. Food and Drug Administration has approved a self-injection version of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult...

Argenx Announces FDA Approval of Vyvgart Hytrulo Prefilled Syringe for Self-Injection

April 10, 2025 – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S....

FDA Approves Expanded Use of Soliris (eculizumab) for Pediatric Myasthenia Gravis, Bringing New Treatment Options for Children

New York, March 10, 2025 – The Muscular Dystrophy Association (MDA) welcomes the U.S. Food and Drug Administration (FDA) approval of the expanded indication of Alexion/AstraZeneca’s eculizumab (So...

FDA Approves Zilbrysq (zilucoplan) for the Treatment of Adults with Generalized Myasthenia Gravis

ATLANTA, Oct. 17, 2023 /PRNewswire/ – UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced that Zilbrysq® (zilucoplan) has been approved by the U.S. Food and Drug ...

FDA Approves Rystiggo (rozanolixizumab-noli) for the Treatment of Adults with Generalized Myasthenia Gravis

Brussels (Belgium) June 27 2023 – UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced Rystiggo® (rozanolixizumab-noli)* has been approved by the U.S. Food and Drug Ad...

FDA Approves Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for Subcutaneous Use in Generalized Myasthenia Gravis

SAN DIEGO, June 20, 2023 /PRNewswire/ – Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that argenx received U.S. Food and Drug Administration (FDA) approval for Vyvgart...

Ultomiris Approved in the US for Adults with Generalised Myasthenia Gravis

First and only long-acting C5 complement inhibitor to demonstrate clinical improvement in patients with generalised myasthenia gravis Ultomiris showed early effect and lasting improvement in...

FDA Approves Vyvgart (efgartigimod alfa-fcab) for the Treatment of Generalized Myasthenia Gravis

Breda, the Netherlands—Dec. 17, 2021 - argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and c...

FDA Approves Soliris (eculizumab) for the Treatment of Patients with Generalized Myasthenia Gravis (GMG)

NEW HAVEN, Conn.--(BUSINESS WIRE) October 23, 2017 --Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today that the U.S. Food and Drug Administration (FDA) has approved Soliris (eculizumab) as...

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