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

SAN DIEGO -- Inebilizumab (Uplizna) improved function and reduced disease severity for up to 52 weeks in generalized ...

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 ...

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

After two initial infusions, patients need one dose of Uplizna every six months. Uplizna (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult ...

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 ...

The table below is a review of notable updates that occurred in March 2025 for investigational products in development (not an inclusive list). Click on the status to view our full coverage ...

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 approves Amgen's Uplizna as the first and only drug for the treatment of immunoglobulin G4-related disease.

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