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- PMLiVE

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

- PMLiVE

NICE recommends two AI-powered software tools for stroke diagnosis in NHS

Brainomix's e-Stroke and Ischemaview’s RapidAI were reported by the health technology assessment agency to improve access to treatment for stroke patients

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

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

- PMLiVE

Pfizer’s RSV vaccine granted MHRA approval to protect infants and older adults

RSV is associated with 15,000 hospital admissions in infants under six months every year in England

- PMLiVE

MHRA extends licence of Vertex’s cystic fibrosis drugs for young children

Kaftrio and Kalydeco are now approved for use in certain patients aged two to five years

- PMLiVE

MHRA authorises world-first gene therapy for two inherited blood disorders

Casgevy is now the first licensed treatment that uses the gene-editing tool CRISPR

- PMLiVE

Eli Lilly’s tirzepatide injection approved by MHRA and FDA for weight loss in adults

The drug has been authorised for use alongside a reduced-calorie diet and physical activity

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