All Generalised myasthenia gravis (gMG) articles
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NewsAmgen wins new European approval for Uplizna in generalised myasthenia gravis
The EC decision clears a new first-in-class approach to manage the rare autoimmune condition.
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J&J biologic Imaavy achieves EU first in generalised myasthenia gravis
The monoclonal antibody becomes the first neonatal Fc receptor (FcRn) blocker to be approved in Europe for the condition.
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Late-stage trial boost for Argenx’s myasthenia gravis drug Vyvgart
The Phase III findings could represent a critical advancement in managing the rare autoimmune disease in those with limited treatment options.
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NewsInnovative biologic for myasthenia gravis granted European approval
The biologic is approved based on Phase III study data in generalised myasthenia gravis (gMG), which demonstrated that rozanolixizumab facilitated statistically significant improvements in gMG-specific outcomes compared to placebo.
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NewsNovel generalised myasthenia gravis treatment approved
A subcutaneous C5 complement inhibitor has been authorised by the European Commission (EC) as a treatment for generalised myasthenia gravis in Europe.
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NewsCHMP’s September 2023 meeting highlights
In its September 2023 meeting, the EMA’s human medicines committee (CHMP) recommended nine medicines for approval and the extension of therapeutic indications for 11 medicines.
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NewsApproval expanded for generalised myasthenia gravis medicine
Extended EU approval of Soliris to paediatric generalised myasthenia gravis (gMG) patients is based on Phase III data which demonstrated improvement in disease severity through 26 weeks.
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NewsFirst RNA CAR-T therapy autoimmunity trial shows potential
A novel RNA CAR-T cell therapy demonstrated long-term clinical benefit for most generalised myasthenia gravis (gMG) patients in a landmark study.
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NewsFirst FcRn blocker approved in UK for myasthenia gravis
VYVGART (efgartigimod alfa-fcab) has been approved for adults with generalised myasthenia gravis by UK Medicines and Healthcare products Regulatory Agency (MHRA).