Amid a swell of regulatory successes in the myasthenia gravis arena this decade, Amgen is wading into the fray with a new ...

Amgen AMGN announced that the FDA has approved its rare disease drug Uplizna (inebilizumab) for a new indication — ...

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 ...

Amgen (AMGN) “announced that the FDA has approved UPLIZNA, inebilizumab-cdon, for the treatment of generalized myasthenia ...

In recent years, five other drugs have been approved to treat gMG, including three complement inhibitors -- eculizumab (Soliris), ravulizumab (Ultomiris), and zilucoplan (Zilbrysq) – and two neonatal ...

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 ...

US biotech Amgen (Nasdaq: AMGN) has won approval from the US regulator for Uplizna (inebilizumab-cdon) to treat adults with ...

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 ...

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 ...

FDA Approves Treatment for gMG FDA Approves Amgen’s UPLIZNA® (inebilizumab-cdon) for Generalized Myasthenia Gravis (gMG), ...

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+.