Marisa Wexler, MS,  senior science writer—

An under-the-skin or subcutaneous injection formulation of efgartigimod has been approved in Japan for use by adults with generalized myasthenia gravis (gMG) who do not sufficiently respond to first-line treatment with steroids or non-steroidal immunosuppressive therapies. In Japan, the now-approved therapy — efgartigimod alfa and hyaluronidase-qvfc — will be…

Treatment with the experimental cell therapy Descartes-08 led to reductions in disease severity that were sustained out to one year for five of seven generalized myasthenia gravis (gMG) patients taking part in a Phase 2a clinical trial. That’s according to new data, announced by the therapy’s developer Cartesian Therapeutics,…

KYV-101, an experimental cell therapy for myasthenia gravis (MG) in development by Kyverna Therapeutics, has been granted fast track status by the U.S. Food and Drug Administration (FDA). The FDA gives this designation to therapies that have the potential to improve care for serious illnesses. The designation is…

A new generic formulation of pyridostigmine bromide — a muscle-strengthening medication sold under the brand name Mestinon — is now available for people with myasthenia gravis (MG) in the U.S. This generic, which like the name-brand therapy is available as an oral syrup at a dose strength of…

A new under-the-skin injectable formulation of Vyvgart (efgartigimod alfa) has been approved by the European Commission for adults with generalized myasthenia gravis (gMG) who are positive for antibodies targeting the acetylcholine receptor (AChR) — the most common type of MG-causing antibody. This subcutaneous (under-the-skin) formulation now can be…

The U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application from Kyverna Therapeutics, giving the company the go-ahead to launch a Phase 2 clinical trial that will test its cell therapy, KYV-101, in people with myasthenia gravis (MG). This is the fifth IND…

The U.S. Food and Drug Administration (FDA) has given Cabaletta Bio the go-ahead to launch a Phase 1/2 clinical trial testing its cell therapy CABA-201 in people with generalized myasthenia gravis (gMG). The upcoming trial is expected to enroll a dozen adults with gMG — six who are positive…

The U.S. Food and Drug Administration (FDA) has approved zilucoplan, a once-daily injection therapy to now be marketed under the brand name Zilbrysq, for adults with generalized myasthenia gravis (gMG) who are positive for antibodies targeting the acetylcholine receptor (AChR). With this approval, Zilbrysq has now become the…

A treatment based on GRO Biosciences‘ ProGly program — which uses specially designed proteins to regulate the immune system — substantially reduced disease activity in an animal model of myasthenia gravis (MG), according to new data presented by the company. “We are greatly encouraged by the results of…

UCB’s zilucoplan and Rystiggo (rozanolixizumab) both were approved in Japan to treat adults with generalized myasthenia gravis (gMG) who lack an adequate response to steroids or other immunosuppressive treatments. “With the approval in Japan of zilucoplan and [Rystiggo], we are very proud and excited to expand our…