Amgen AMGN announced that the FDA has approved its rare disease drug Uplizna (inebilizumab) for a new indication. The ...

Acquired as part of its $27.8 billion takeover of Horizon Therapeutics in 2023, CD19-targeting Uplizna (inebilizumab) is the ...

Inebilizumab-cdon (Uplizna; Amgen) was approved as the first and only treatment for immunoglobulin G4–related disease ...

These are data to week 26 on the monoclonal antibody and antineoplastic agent; data out to week 52 of the MINT trial will be ...

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

In the coming two weeks, the FDA is expected to announce three big decisions, including one for a dry eye disease therapy.

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

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

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.

The FDA also granted UPLIZNA Orphan Drug Designation for the treatment of generalized myasthenia gravis (gMG). Regulatory filing activities are underway for gMG with submission anticipated to be ...

Amgen has been evaluating Uplizna for treating generalized myasthenia gravis (gMG), another immune-mediated disease. Last month, the company reported the latest data from the phase III MINT study ...