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 ...

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 ...

Amgen’s (AMGN) blinatumomab was granted FDA orphan designation as a treatment of acute lymphoblastic leukemia, according to a post to the agency’s ...

And the FDA has approved Amgen’s Uplizna for adults with antibody-positive generalized myasthenia gravis, adding a ...

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+.

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 ...

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 ...

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

Generalized myasthenia gravis is Uplizna’s second new indication this year, after the FDA cleared the anti-CD19 antibody for ...

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 ...

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