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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.
The Medicines and Healthcare products Regulatory Agency (MHRA) is asking patients who use a continuous glucose monitor (CGM) or insulin pump to report any safety problem with their device through the MHRA Yellow Card scheme …
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 launched its ambitious new business plan for 2024/25, setting out the agency’s core focus of enabling access to innovative healthcare products whi…
Information on the other regulatory bodies responsible for e-cigarette and vape products.
The Medicines and Healthcare products Regulatory Agency (MHRA) has on 25 September approved leniolisib phosphate (Joenja) to treat a rare immune disease known as activated phosphoinositide 3-kinase delta syndrome or APDS in…
The Access Consortium is offering joint pipeline meetings to pharmaceutical and biotechnology companies.
The MHRA, is calling for applications for manufacturers and developers of Artificial Intelligence (AI) medical devices, to join the AI Airlock regulatory sandbox.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 20 September, approved the new medicine fruquintinib (Fruzaqla) to treat adult patients with metastatic colorectal cancer (CRC). It is used when othe…
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.
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