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Merck KGaA given FDA Fast Track designation for generalised myasthenia gravis drug

Cladribine capsules could become the first ever oral treatment for gMG

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EC approves argenx’s subcutaneous Vyvgart for rare autoimmune disease CIPD

The drug has been authorised as a monotherapy for adults with progressive or relapsing active cases

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MHRA approves Bavarian Nordic’s chikungunya vaccine Vimkunya

Approximately 620,000 cases of the mosquito-borne viral disease were reported worldwide in 2024

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Johnson & Johnson’s Imaavy granted FDA approval for rare autoimmune disease gMG

Myasthenia gravis affects an estimated 700,000 people worldwide

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FDA approves pre-filled syringe version of argenx’s immune disorder drug Vyvgart

The authorisation will give patients the flexibility to decide when and where they receive treatment

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Amgen’s Uplizna shows promise in phase 3 generalised myasthenia gravis study

Regulatory submissions are expected to be complete in the first half of this year

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MHRA urges companies to prepare for Windsor Framework for medicines

The new UK-wide arrangements for medicines will come into effect on 1 January 2025

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Amgen shares positive late-stage results for Uplizna in generalised myasthenia gravis

The company said it is planning to file for US approval of the drug in this indication

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J&J’s nipocalimab shows sustained disease control in adolescents with generalised myasthenia gravis

The severity of the rare autoimmune disease is heightened in paediatric patients

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Ipsen’s Iqirvo approved by MHRA to treat primary biliary cholangitis in adults

Approximately 25,000 people in the UK are affected by the rare liver disease

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Pfizer/BioNTech’s Omicron JN.1-adapted COVID-19 vaccine approved by MHRA

The UK regulator has approved four versions of the updated vaccine for adults and children from infancy

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Novo Nordisk’s semaglutide approved by MHRA to prevent cardiovascular event risk

Approximately 7.6 million people are living with heart and circulatory diseases in the UK

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