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

Autoimmune generalized myasthenia gravis is a disease that manifests with fluctuating muscle weakness. Inebilizumab is a monoclonal antibody that depletes CD19+ B cells, which are central to ...

Leerink analysts noted, however, that Uplizna’s slow onset of therapeutic efficacy compares unfavorably to would-be ...

This study was supported by Amgen. Nowak reported relationships with the National Institutes of Health, Genentech, Alexion ...

With a label expansion for Uplizna pushing the drug into an untouched rare disease market, Amgen is getting its money’s worth ...

Inebilizumab showed significant efficacy in improving MG-ADL and QMG scores in gMG patients compared to placebo over 26 weeks. The trial included 238 patients, with 80% AChR+ and 20% MuSK+, and ...

The FDA approved Amgen ’s anti-CD19 therapy Uplizna Thursday for use in patients with IgG4-related disease. Uplizna is the ...

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.

As Amgen waits for an FDA decision on a second ... MINT trial in adults living with autoimmune disorder generalised myasthenia gravis (gMG) – which can lead to muscle weakness, breathing ...