News

FDA approves inebilizumab, now Uplizna, to treat adults with gMG

The U.S. Food and Drug Administration (FDA) has approved inebilizumab as a treatment for generalized myasthenia gravis (gMG). The newly approved therapy, which developer Amgen will market under the brand name Uplizna, is specifically indicated for adults with gMG who are positive for antibodies targeting the acetylcholine…

Imaavy approved in EU to treat gMG patients 12 and older

Imaavy (nipocalimab) has been approved in the European Union as an add-on to standard of care treatment for adults and adolescents, ages 12 and older, with generalized myasthenia gravis (gMG) and self-reactive antibodies targeting the acetylcholine receptor (AChR) or muscle-specific kinase (MuSK). The decision by the European Commission makes…

New enzyme may disarm antibodies driving myasthenia gravis: Study

An enzyme, called S-1117, can disarm self-reactive immunoglobulin G (IgG) antibodies targeting the acetylcholine receptor (AChR) that drive most cases of myasthenia gravis (MG), according to a study that used blood samples from patients. “This study presents S-1117, an IgG-specific protease [a protein-degrading enzyme], as a promising therapeutic approach…

FDA puts experimental gMG therapy cladribine on fast track

Note: This story was updated Nov. 26, 2025, to correct that the cladribine formulation being tested as a potential gMG treatment differs from the one used in Mavenclad, an approved therapy for multiple sclerosis. The U.S. Food and Drug Administration (FDA) has granted fast track designation to cladribine, an…

Patient registry launches to track myasthenia gravis care

The first patient has been enrolled in a myasthenia gravis (MG) registry to collect clinical information from real-world settings across the U.S., with the aim of better understanding the disease and ultimately improving care. Thermo Fisher Scientific’s newly launched registry is recruiting people with the ocular and generalized…