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.