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This national approval was granted after an Access Consortium new active substance work-sharing initiative (NASWSI) procedure.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 14 February 2025, approved efanesoctocog alfa (brand name Altuvoct) to be used to treat and prevent bleeding in patients aged 2 years and above with s…
A review by 2 specialists will remain in place for patients starting valproate under 55 years of age.
Gozetotide binds to the cancer cells with prostate-specific membrane antigen (PSMA) on their surface, making them visible during the PET scan.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 4 February 2025, approved the vaccine chikungunya vaccine (live) (brand name IXCHIQ) to protect adults against chikungunya disease, caused by the chik…
The draft MHRA guidance aims to clarify and streamline pathways for bringing these therapies through to patients, without compromising on robust safety principles
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 angioedem…
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…
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).
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 t…
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
From coughs and sneezes to mental health apps, these tips from the MHRA will help you stay safe during the festive season and beyond
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