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Submission and approval enabled of the first application for In Vitro Diagnostic devices under the EU IVDR in Northern Ireland due to recent implementation of a submission route for manufacturers for performance studies.
New strategy aims to transform the way we provide information on the risks and safety of medicines and medical devices.
Men taking valproate and their partners are being advised by the Medicines and Healthcare products Regulatory Agency (MHRA) to use effective contraception because of new data suggesting a potential small increased risk of ha…
Following a thorough review, the Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that the available evidence does not establish a causal relationship between Glucagon-Like Peptide-1 (GLP-1) receptor …
As the new school year looms, the MHRA sets out key advice on children's medicines and medical devices.
The MHRA has approved an adapted Moderna COVID-19 vaccine (Spikevax) that targets the JN.1 COVID-19 subvariant.
Dr Junaid Bajwa, Professor Graham Cooke, Dr Paul Goldsmith and Rajakumari Long have had their appointments as Non-Executive Directors (NEDs) of the Medicines and Healthcare products Regulatory Agency extended from 1 Sept…
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 22 August 2024, approved a product licence for the medicine lecanemab (Leqembi) for use in the early stages of Alzheimer’s disease, following a thorou…
Zolbetuximab (Vyloy) is a monoclonal antibody that can recognise and attach itself to certain cancer cells to destroy them.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 17 July 2024, approved the medicine capivasertib (Truqap) for patients with advanced hormone receptor (HR) positive, human epidermal growth factor rec…
Key advice on medicines and medical devices for the holiday season.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 24 July, approved an adapted Pfizer/BioNTech COVID-19 vaccine (Comirnaty) that targets the JN.1 COVID-19 subvariant.
Semaglutide is the first weight loss drug approved in the UK as a preventative treatment for those with established cardiovascular disease
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 19 July 2024, approved the first generic raltegravir medicines to treat adult and paediatric HIV patients who weigh at least 40kg.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 17 July 2024, approved the medicine vibegron (Obgemsa) to treat the symptoms of overactive bladder (OAB) syndrome in adults. Symptoms may include a …
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new formulation of the medicine ocrelizumab (Ocrevus 920mg solution for injection) to treat relapsing forms of multiple sclerosis (RMS) and primar…
A man who had unlicensed medicines sent to his parents’ address, has been sentenced at Southwark Crown Court to a term of imprisonment, having earlier been found guilty of criminal activity in May. The sentencing follows an …
Migraine and antiseizure medication topiramate must no longer be prescribed to women and girls unless they fulfil the requirements of a Pregnancy Prevention Programme.
This initiative signals an important step towards a new regulatory framework for medical devices in Great Britain which protects public health, ensures access to MedTech innovations, and maintains an attractive market for in…
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (21 May 2024) launched a four-week consultation which will support improved safety for certain high risk in vitro diagnostic (IVD) devices.
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