In today’s Pharma Pulse, the FDA approves Amgen’s Uplizna (inebilizumab-cdon), the first CD19-targeted therapy for gMG with convenient twice-yearly dosing, and much more.
Amid a swell of regulatory successes in the myasthenia gravis arena this decade, Amgen is wading into the fray with a new ...
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Here's how AMGN benefits from FDA nod to Uplizna in myasthenia gravis
Amgen AMGN announced that the FDA has approved its rare disease drug Uplizna (inebilizumab) for a new indication — ...
Generalized myasthenia gravis is Uplizna’s second new indication this year, after the FDA cleared the anti-CD19 antibody for ...
FDA Approves Treatment for gMG FDA Approves Amgen’s UPLIZNA® (inebilizumab-cdon) for Generalized Myasthenia Gravis (gMG), ...
Amgen (AMGN) “announced that the FDA has approved UPLIZNA, inebilizumab-cdon, for the treatment of generalized myasthenia ...
FDA Approves Amgen's Uplizna for Generalized Myasthenia Gravis With Positive AChR or MuSK Antibodies
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 ...
Advances Amgen (AMGN)'s Leadership in CD19 Directed, B-Cell Depletion Therapies for Serious Autoimmune Diseases Including NMOSD, IgG4-RD and gMG THOUSAND OAKS, Calif., April 3, 2025 /PRNewswire/ -- ...
The U.S. Food and Drug Administration (FDA) on Thursday approved Amgen Inc.’s (NASDAQ:AMGN) Uplizna (inebilizumab-cdon) as the first and only treatment for adult patients with Immunoglobulin ...
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 ...
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 ...
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