FDA approves Uplinza for adults with generalised myasthenia gravis

Amgen

11 December 2025 - Amgen today announced that the US FDA has approved Uplinza (inebilizumab-cdon) for the treatment of generalised myasthenia gravis in adults who are anti-acetylcholine receptor and anti-muscle specific tyrosine kinase antibody positive. 

The approval offers patients a new targeted treatment option that has the potential for long-term disease control with just two doses a year, after two initial loading doses.

Read Amgen press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Registration