Medicines and Healthcare products Regulatory Agency
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The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 23 October 2024, approved a licence for the medicine donanemab (Kisunla) for use in the early stages of Alzheimer’s disease, following a thorough review of the benefits and risks.
The new legislation will introduce clearer and risk-proportionate requirements that improve the safety of medical devices across Great Britain and provide certainty for manufacturers ahead of introducing the wider future regulatory regime.
The UK will be the first country in the world to introduce a tailored framework for the regulation of innovative products manufactured at or close to the location where a patient receives care.
Eplontersen approved to treat adults with rare inherited nerve disease or polyneuropathy
Press release
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved eplontersen (Wainzua) to treat adults with polyneuropathy associated with hereditary transthyretin amyloidosis (ATTRv), which is a rare progressive condition that runs in families caused by a protein called transthyretin (TTR).
Elafibranor approved to treat adults with a rare liver disease known as primary biliary cholangitis
Press release
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved elafibranor (Iqirvo) to treat adult patients with a rare type of liver disease known as primary biliary cholangitis (PBC).
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 10 October, approved an adapted Pfizer/BioNTech COVID-19 vaccine (Comirnaty) that targets the KP.2 COVID-19 subvariant for adults.
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The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK.
MHRA is an executive agency, sponsored by the Department of Health and Social Care.
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10 South Colonnade
London
E14 4PU
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020 3118 9803
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MHRA10 South Colonnade
London
E14 4PU
United Kingdom
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10 South Colonnade
London
E14 4PU
United Kingdom