Lindsey Shapiro, PhD,  science writer—

The U.S. Food and Drug Administration (FDA) has approved nipocalimab as a treatment for adults and adolescents, ages 12 and older, with generalized myasthenia gravis (gMG) who have antibodies against the acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) proteins. The newly approved therapy will be sold by developer…

Disease-causing antibodies from different myasthenia gravis (MG) patients bind to and affect the function of acetylcholine receptors (AChRs) in different ways, a study finds. While the mechanism varied, all the antibodies ultimately interfered with the usual activation of AChRs, which are the proteins important for normal muscle contractions commonly…

The U.S. Food and Drug Administration (FDA) has approved a version of Argenx’s Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) that can be self-administered via a prefilled syringe to treat generalized myasthenia gravis (gMG). These prefilled syringes are indicated for adults with gMG who are positive for antibodies against…

Investigational therapy batoclimab eased disease severity for adults with generalized myasthenia gravis (gMG) in a Phase 3 trial, but the treatment’s developer said it’s not planning to seek regulatory approval of the treatment for gMG in the U.S. Immunovant, a Roivant subsidiary, is instead focused on using the…

A digital tool developed by BioSensics for remotely monitoring myasthenia gravis (MG) symptoms was found to be feasible in a small clinical study. BioDigit MG includes various assessments that can be completed on a tablet, along with wearable sensors to collect information about physical activity and posture…

More than two years of treatment with Zilbrysq (zilucoplan) continues to be associated with sustained clinical responses in adults with generalized myasthenia gravis (gMG), according to interim analyses of the long-term Phase 3 RAISE-XT extension study. These new findings, consistent with earlier interim trial analyses, were presented…

The U.S. Food and Drug Administration (FDA) has approved the expanded use of Soliris (eculizumab) for treating children with generalized myasthenia gravis (gMG), ages 6 and older, who are positive for antibodies against the acetylcholine receptor (AChR). The infusion therapy marketed by Alexion, AstraZeneca Rare Disease was…

The National Organization for Rare Disorders (NORD) is seeking participants for its survey-based study Living Rare, which aims to better understand the real-world lived experiences of people in the U.S. with rare diseases. Living Rare, the first large-scale study of its kind in the U.S., seeks to capture the…

Cartesian Therapeutics has aligned with the U.S. Food and Drug Administration (FDA) on the design of the planned Phase 3 AURORA trial that will test its investigational cell therapy Descartes-08 in people with myasthenia gravis (MG). The FDA, under its special protocol assessment process, provided written agreement…

The investigational cell therapy Descartes-08 led to durable reductions in disease severity for people with myasthenia gravis (MG), according to updated Phase 2b trial results presented by Cartesian Therapeutics, its developer. “Data reported today add to the growing body of evidence supporting the potential for Descartes-08 to provide…