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New guidance helps manufacturers navigate medical device regulations and protect users of digital mental health technologies.
It is the only example globally of an end-to-end access pathway, where a medicine developer can work collaboratively with the national health system, the regulator, and health technology assessment bodies from the early stag…
The Medicines and Healthcare products Regulatory Agency (MHRA) last year stopped criminals making more than £7.5 million linked to the illegal trade in medicines.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 24 January 2025, approved garadacimab (brand name Andembry) for patients aged 12 years and older with hereditary angioedema (HAE) to prevent angioedema attacks.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine aprocitentan (Jeraygo) to treat hypertension (high blood pressure) in adults whose blood pressure cannot be adequately controlled by at least three other medicines (also known as resistant hypertension…
As with any medicine, the MHRA will keep the safety and effectiveness of seladelpar under close review.
A suite of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA).…
Changes to the Misuse of Drugs Act 1971 to control 22 substances, with 2-benzyl benzimidazole variants (nitazenes) falling under a new generic definition.
Professor Anthony Harnden has officially started his role as Chair of the Medicines and Healthcare products Regulatory Agency (MHRA).
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved (27 December 2024) the medicine sotatercept (Winrevair) to treat pulmonary arterial hypertension (PAH).
…The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 31 December 2024, approved the medicine tarlatamab (Imdylltra) to treat adult patients with small cell lung cancer (SCLC) that has spread throughout the lungs and/or to other parts of the body.…
The MHRA’s Criminal Enforcement Unit works to identify and prevent the illegal sale of weight-loss medicines online.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (20 December 2024) granted a conditional marketing authorisation for the medicine givinostat (Duvyzat) to treat Duchenne muscular dystrophy (DMD).
The amended regulatory framework will speed up trial approvals and encourage innovation in trial design without compromising patient safety
20 new clinical research hubs to be set up across UK to accelerate research into the next generation of treatments.
From coughs and sneezes to mental health apps, these tips from the MHRA will help you stay safe during the festive season and beyond
Existing emergency measures banning the sale and supply of puberty-suppressing hormones will be made indefinite, following official advice from medical experts.
The Medicines and Healthcare products Regulatory Agency has approved the medicine delgocitinib (Anzupgo) to treat moderate to severe chronic hand eczema in adults when topical corticosteroids are inadequate or inappropriate.…
The pilot scheme, AI Airlock, is designed to help test and improve the rules for AI-powered medical devices to ensure they reach patients quickly, safely and effectively.
With industry already showing a very high level of readiness, the MHRA is reminding remaining marketing authorisation holders to ensure they are prepared for the new packaging and labelling measures
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