In recent years, five other drugs have been approved to treat gMG, including three complement inhibitors -- eculizumab ...
FDA Approves Treatment for gMG FDA Approves Amgen’s UPLIZNA® (inebilizumab-cdon) for Generalized Myasthenia Gravis (gMG), ...
The Muscular Dystrophy Association (MDA) recognizes the U.S. Food and Drug Administration (FDA) approval of Amgen's UPLIZNA(R) (inebilizumab-cdon) for the treatment of generalized myasthenia gravis ...
Generalized myasthenia gravis is Uplizna’s second new indication this year, after the FDA cleared the anti-CD19 antibody for ...
Amid a swell of regulatory successes in the myasthenia gravis arena this decade, Amgen is wading into the fray with a new ...
Jonathan Strober, MD, discusses advancements in pediatric myasthenia gravis, emphasizing the need for better treatment standards and effective patient care strategies.
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who ...
Inebilizumab-cdon is approved for anti-acetylcholine receptor and anti-muscle specific tyrosine kinase antibody–positive generalized myasthenia gravis, based on MINT trial results. Inebilizumab gains ...
The FDA’s approval of Uplizna for antibody-positive generalized myasthenia gravis introduces a twice-yearly CD19-targeted therapy option for the rare autoimmune condition. The FDA has approved Amgen’s ...
Amgen receives US FDA approval for Uplizna to treat Adults with generalized myasthenia gravis: Thousand Oaks, California Saturday, December 13, 2025, 11:00 Hrs [IST] Amgen announc ...
And the FDA has approved Amgen’s Uplizna for adults with antibody-positive generalized myasthenia gravis, adding a ...
The phase 3 MINT study evaluated inebilizumab, a CD-19 directed cytolytic antibody, in 238 patients with gMG, including those who were anti-AChR-Ab+ and anti-MuSK-Ab+.