tag:www.gov.uk,2005:/search/news-and-communicationsNews and communications2025-04-25T11:54:57+01:00HM Governmenttag:www.gov.uk,2005:/government/news/acoramidis-approved-to-treat-wild-type-or-variant-transthyretin-amyloidosis-in-adults-with-cardiomyopathy2025-04-25T11:54:57+01:00Acoramidis approved to treat wild-type or variant transthyretin amyloidosis in adults with cardiomyopathyAs with all products, the MHRA will keep its safety under close review.tag:www.gov.uk,2005:/government/news/obecabtagene-autoleucel-conditionally-approved-to-treat-adults-with-relapsed-or-refractory-b-cell-precursor-acute-lymphoblastic-leukaemia2025-04-25T00:00:00+01:00Obecabtagene autoleucel conditionally approved to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemiaAs with all products, the MHRA will keep its safety under close review.tag:www.gov.uk,2005:/government/news/mhra-approves-first-uk-treatment-for-friedreichs-ataxia-omaveloxolone2025-04-23T16:26:45+01:00MHRA approves first UK treatment for Friedreich’s ataxia, omaveloxoloneAs with all products, we will keep its safety under close review.tag:www.gov.uk,2005:/government/news/marstacimab-approved-to-treat-patients-aged-12-years-and-above-weighing-at-least-35-kg-with-haemophilia-a-or-b2025-04-22T11:09:20+01:00Marstacimab approved to treat patients aged 12 years and above (weighing at least 35 kg) with haemophilia A or BAs with all products, the MHRA will keep its safety under close review.tag:www.gov.uk,2005:/government/news/professor-claire-stewart-appointed-to-the-commission-on-human-medicines-as-three-members-reappointed2025-04-17T14:12:39+01:00Professor Claire Stewart appointed to the Commission on Human Medicines as three members reappointedThe appointment will involve a time commitment of 22 days per year. Remuneration for the role will be at a rate of £325 per attendance and preparation for meetings.
tag:www.gov.uk,2005:/government/news/trastuzumab-deruxtecan-approved-to-treat-adults-with-her2-positive-cancer-that-has-spread-or-cannot-be-removed-by-surgery2025-04-09T11:17:51+01:00Trastuzumab deruxtecan approved to treat adults with HER2-positive cancer that has spread or cannot be removed by surgery As with all products, the MHRA will keep its safety under close review.tag:www.gov.uk,2005:/government/news/eplontersen-approved-to-treat-adults-with-rare-inherited-nerve-disease-or-polyneuropathy2025-04-04T11:34:24+01:00Eplontersen approved to treat adults with rare inherited nerve disease or polyneuropathyThe Medicines and Healthcare products Regulatory Agency (MHRA) has approved eplontersen (Wainzua) to treat adults with polyneuropathy associated with hereditary transthyretin amyloidosis (ATTRv), which is a rare progressive …tag:www.gov.uk,2005:/government/news/world-first-as-mhra-approves-trofolastat-for-diagnostic-imaging-of-prostate-cancer-in-men2025-03-28T10:04:12+00:00World first as MHRA approves trofolastat for diagnostic imaging of prostate cancer in men As with all products, the MHRA will keep its safety under close review.tag:www.gov.uk,2005:/government/news/new-study-shows-mhra-collaboration-with-hospital-dna-sequencing-service-cuts-time-to-diagnose-infections2025-03-07T17:07:02+00:00New study shows MHRA collaboration with hospital DNA sequencing service cuts time to diagnose infectionsIn a UK-first, the Medicines and Healthcare products Regulatory Agency (MHRA) and Barts Health NHS Trust have developed a DNA sequencing approach that can be implemented onsite in hospitals so they can diagnose bacterial inf…tag:www.gov.uk,2005:/government/news/triple-combination-medicine-deutivacaftortezacaftorvanzacaftor-approved-for-cystic-fibrosis2025-03-07T00:00:00+00:00Triple combination medicine deutivacaftor/tezacaftor/vanzacaftor approved for cystic fibrosisAs with all products, the MHRA will keep its safety under close reviewtag:www.gov.uk,2005:/government/news/lazertinib-approved-for-use-in-combination-with-amivantamab-for-the-treatment-of-adults-with-non-small-cell-lung-cancer2025-03-06T00:00:00+00:00Lazertinib approved for use in combination with amivantamab for the treatment of adults with non-small cell lung cancer As with all products, the MHRA will keep its safety under close review.
tag:www.gov.uk,2005:/government/news/mresvia-rsv-vaccine-approved-to-protect-patients-aged-60-and-over2025-02-28T10:31:37+00:00mRESVIA RSV vaccine approved to protect patients aged 60 and overA study found that around 4 months after vaccination, people who received the RSV vaccine had a 79% reduction in their risk of getting lower respiratory tract disease caused by RSV, compared with those who received placebo.
tag:www.gov.uk,2005:/government/news/nemolizumab-approved-to-treat-prurigo-nodularis-and-atopic-dermatitis-eczema-for-patients-in-the-uk2025-02-17T15:32:31+00:00Nemolizumab approved to treat prurigo nodularis and atopic dermatitis (eczema) for patients in the UKThis national approval was granted after an Access Consortium new active substance work-sharing initiative (NASWSI) procedure.tag:www.gov.uk,2005:/government/news/efanesoctocog-alfa-approved-to-prevent-and-treat-bleeding-in-children-and-adults-with-severe-or-moderate-haemophilia-a2025-02-14T14:57:58+00:00Efanesoctocog alfa approved to prevent and treat bleeding in children and adults with severe or moderate haemophilia AThe 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…tag:www.gov.uk,2005:/government/news/gozetotide-approved-for-the-treatment-of-prostate-cancer2025-02-12T00:00:00+00:00Medical imaging agent gozetotide approved for diagnosis of prostate cancerGozetotide binds to the cancer cells with prostate-specific membrane antigen (PSMA) on their surface, making them visible during the PET scan.tag:www.gov.uk,2005:/government/news/ixchiq-vaccine-approved-to-protect-adults-against-chikungunya2025-02-04T15:51:27+00:00IXCHIQ vaccine approved to protect adults against ChikungunyaThe 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…tag:www.gov.uk,2005:/government/news/digital-mental-health-technologies-guidance-launched-to-help-manufacturers-and-safeguard-users2025-02-03T00:00:00+00:00Digital mental health technologies guidance launched to help manufacturers and safeguard usersNew guidance helps manufacturers navigate medical device regulations and protect users of digital mental health technologies.tag:www.gov.uk,2005:/government/news/uk-patients-enabled-access-to-transformative-new-medicines-in-shortest-time-possible-via-new-integrated-innovative-licensing-and-access-pathway2025-01-30T09:05:01+00:00UK patients enabled access to transformative new medicines in shortest time possible via new, integrated Innovative Licensing and Access Pathway 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…tag:www.gov.uk,2005:/government/news/garadacimab-andembry-approved-to-prevent-angioedema-attacks2025-01-24T00:00:00+00:00Garadacimab (andembry) approved to prevent angioedema attacksThe 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…tag:www.gov.uk,2005:/government/news/aprocitentan-approved-to-treat-adults-with-hypertension-whose-blood-pressure-cannot-be-controlled-by-other-medications2025-01-17T13:53:25+00:00Aprocitentan approved to treat adults with hypertension whose blood pressure cannot be controlled by other medicationsThe 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…