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Kalydeco

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MHRA approves argenx’s subcutaneous generalised myasthenia gravis therapy

Vyvgart is now authorised in the UK for both intravenous and subcutaneous administration

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GSK’s Omjjara approved by MHRA to treat myelofibrosis patients with anaemia

The rare blood cancer affects approximately one in every 500,000 people worldwide

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More than £30m worth of illegal medicines seized in UK during 2023

The MHRA and law enforcement partners seized over 15.5 million doses of illegal medicines

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Novavax’s XBB.1.5-adapted COVID-19 vaccine receives MHRA approval

Individuals in the UK aged 12 years and older will be eligible to receive Nuvaxovid XBB.1.5

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MHRA approves UCB’s Zilbrysq as generalised myasthenia gravis add-on therapy

The autoimmune disease has a global prevalence of 100 to 350 cases per every one million people

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FDA approves Vertex/CRISPR’s Casgevy gene therapy for beta thalassaemia

The companies estimate that approximately 1,000 patients in the US will be eligible for the one-time treatment

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MHRA approves Santhera’s Duchenne muscular dystrophy drug Agamree

The rare muscle-wasting disorder is estimated to affect one in 3,500 male births worldwide

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MHRA sets out regulatory roadmap to support safe access to medical technology

The new regulations will ensure patients have access to the medical devices they need without delay

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MHRA approves Menarini Stemline’s Korserdu for advanced or metastatic breast cancer

More than 55,000 new cases of breast cancer are diagnosed each year in the UK

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MHRA launches new International Recognition Procedure to help bring medicines to UK patients

The agency will partner with regulators in several countries including the EU and US

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Bristol Myers Squibb’s Opdualag approved by MHRA for advanced melanoma

Approximately 17,000 cases of melanoma are diagnosed in the UK every year

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CHMP recommends gene therapy for beta thalassemia and sickle cell disease

If approved, Casgevy will be the only genetic therapy in the EU to treat these conditions

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