In Phase III MINT trial, Uplizna (inebilizumab) demonstrated significant short-term efficacy and a manageable safety profile ...

The FDA has approved Uplizna (inebilizumab-cdon) for the treatment of immunoglobulin G4-related disease in adult patients.

Inebilizumab, a first-in-class CD19+ B-cell–targeting agent, is safe and effective for up to 1 year in patients with ...

Inebilizumab (Uplizna) improved function and reduced disease severity for up to 52 weeks in generalized myasthenia gravis ...

Uplizna is the first approved treatment for immunoglobulin G4-related disease (IgG4-RD), a chronic inflammatory condition ...

US FDA approves Amgen’s Uplizna to treat IgG4-related disease: Thousand Oaks, California Saturday, April 5, 2025, 11:00 Hrs [IST] Amgen announced that the US Food and Drug Admin ...

Amgen AMGN announced that the FDA has approved its rare disease drug Uplizna (inebilizumab) for a new indication. The regulatory body has now approved Uplizna for the treatment of adults living ...

Inebilizumab-cdon was previously approved by the FDA for neuromyelitis optica spectrum disorder (NMOSD) in adults who are ...

Thousand Oaks: Amgen has announced that the Company has received approval from the U.S. Food and Drug Administration (FDA) for UPLIZNA as the first and only treatment for adults living with ...

The FDA on Thursday gave the green light to Uplizna in IgG4-related disease, making it the first and only approved treatment ...

The US Food and Drug Administration (FDA) has approved Uplizna (inebilizumab-cdon) as the first and only treatment for adults ...

The FDA approved Amgen's Uplizna as the first treatment for IgG4-RD. The decision is backed by the MITIGATE trial, showing reduced flares and sustained efficacy.