Plans to establish new partnerships with other international drug regulators could result in the approval of new drugs for use in the UK. The UK regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), will receive 10 million pounds to assist in streamlining the approval process for new medical products, according to Chancellor Jeremy Hunt. […]
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In addition to the capacity already provided for these kinds of products by BSI Assurance UK Ltd. and SGS United Kingdom Ltd., UL International UK Limited has had their current designation as an approved body extended to include almost all Part IV In-vitro Diagnostics Medical Devices. For UKCA certification, manufacturers of self-test IVDs and those […]
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The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Beyfortus (nirsevimab) to treat respiratory syncytial virus (RSV) lower respiratory tract disease in the infants and newborns during their first RSV season. This approval come after the European Commission approve Beyfortus earlier this month. According to studies, about 90 percent of children by 2 […]
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Oncopeptides AB, a biotech company focused on R&D of development of therapies to treat haematological diseases, announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Pepaxti in combination with dexamethasone in the United Kingdom. The approval of Pepaxti in the United Kingdom is an important milestone for the […]
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The UK Medicines and Healthcare Products Regulatory Agency (MHRA), has approved Nuvaxovid, COVID-19 vaccine developed by Novavax, as a vaccine booster for 12 years to 17 years old children. The approval follows a review of the safety, effectiveness, and quality of the COVID-19 vaccine in the age group, and expert advice from the Commission on […]
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The UK medical devices regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), has announced the changes to UK medical device regulatory will be postponed from July 1, 2023 to July 1, 2024. The UK MHRA is currently in the process of significantly revising UK medical device legislation. As one of the first reforms of […]
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The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has now granted approval for faricimab developed by Roche for the individuals with the wet age-related macular degeneration (wet AMD) and the impairment in vision because of the diabetic macular oedema (DMO). An eye injection known as faricimab has been bispecific antibody that […]
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The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted the Conditional Marketing Authorization (CMA) to the inactivated covid-19 vaccine candidate ‘VLA2001’ developed by Valneva in the adults aged between 18 to 50 years. The novel corona virus vaccine of Valneva has been indicated for the initial active immunization of the […]
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The MHRA of the United Kingdom has approved a new corona virus vaccine for use, and the vaccine is manufactured by Valneva by using a more traditional technology, which has been similar to how the polio and flu vaccine shots are produced. The covid-19 vaccine of Valneva contains a whole copy of the novel corona […]
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The UK MHRA (Medicines and Healthcare products Regulatory Agency) has now granted the authorization to the Evusheld of AstraZeneca for the pre-exposure prophylaxis (PrEP) against the novel corona virus, and the Evusheld has been a cocktail of the two monoclonal long-acting antibodies, along with the cilgavimab and tixagevimab. The company ‘AstraZeneca’ has now licensed the […]
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