tag:www.gov.uk,2005:/search/news-and-communications News and communications 2025-04-09T11:17:51+01:00 HM Government 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-surgery 2025-04-09T11:17:51+01:00 Trastuzumab 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-polyneuropathy 2025-04-04T11:34:24+01:00 Eplontersen approved to treat adults with rare inherited nerve disease or polyneuropathy The 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-men 2025-03-28T10:04:12+00:00 World 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-infections 2025-03-07T17:07:02+00:00 New study shows MHRA collaboration with hospital DNA sequencing service cuts time to diagnose infections In 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-fibrosis 2025-03-07T00:00:00+00:00 Triple combination medicine deutivacaftor/tezacaftor/vanzacaftor approved for cystic fibrosis As with all products, the MHRA will keep its safety under close review tag:www.gov.uk,2005:/government/news/lazertinib-approved-for-use-in-combination-with-amivantamab-for-the-treatment-of-adults-with-non-small-cell-lung-cancer 2025-03-06T00:00:00+00:00 Lazertinib 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-over 2025-02-28T10:31:37+00:00 mRESVIA RSV vaccine approved to protect patients aged 60 and over A 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-uk 2025-02-17T15:32:31+00:00 Nemolizumab approved to treat prurigo nodularis and atopic dermatitis (eczema) for patients in the UK This 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-a 2025-02-14T14:57:58+00:00 Efanesoctocog alfa approved to prevent and treat bleeding in children and adults with severe or moderate haemophilia A 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� tag:www.gov.uk,2005:/government/news/gozetotide-approved-for-the-treatment-of-prostate-cancer 2025-02-12T00:00:00+00:00 Medical imaging agent gozetotide approved for diagnosis of prostate cancer Gozetotide 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-chikungunya 2025-02-04T15:51:27+00:00 IXCHIQ vaccine approved to protect adults against Chikungunya 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� tag:www.gov.uk,2005:/government/news/digital-mental-health-technologies-guidance-launched-to-help-manufacturers-and-safeguard-users 2025-02-03T00:00:00+00:00 Digital mental health technologies guidance launched to help manufacturers and safeguard users New 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-pathway 2025-01-30T09:05:01+00:00 UK 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-attacks 2025-01-24T00:00:00+00:00 Garadacimab (andembry) approved to prevent angioedema attacks 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� tag:www.gov.uk,2005:/government/news/aprocitentan-approved-to-treat-adults-with-hypertension-whose-blood-pressure-cannot-be-controlled-by-other-medications 2025-01-17T13:53:25+00:00 Aprocitentan approved to treat adults with hypertension whose blood pressure cannot be controlled by other medications 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� tag:www.gov.uk,2005:/government/news/seladelpar-approved-to-treat-adult-patients-in-the-uk-with-liver-illness 2025-01-16T15:29:49+00:00 Seladelpar approved to treat adult patients in the UK with liver illness As with any medicine, the MHRA will keep the safety and effectiveness of seladelpar under close review.� tag:www.gov.uk,2005:/government/news/sotatercept-approved-to-treat-adult-patients-with-pulmonary-arterial-hypertension-pah 2024-12-31T12:13:25+00:00 Sotatercept approved to treat adult patients with pulmonary arterial hypertension (PAH) The Medicines and Healthcare products Regulatory Agency (MHRA) has approved (27 December 2024) the medicine sotatercept (Winrevair) to treat pulmonary arterial hypertension (PAH).  tag:www.gov.uk,2005:/government/news/tarlatamab-approved-to-treat-adult-patients-with-small-cell-lung-cancer 2024-12-31T00:00:00+00:00 Tarlatamab approved to treat adult patients with small cell lung cancer  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� tag:www.gov.uk,2005:/government/news/givinostat-conditionally-approved-to-treat-patients-with-duchenne-muscular-dystrophy-dmd 2024-12-20T16:04:55+00:00 Givinostat conditionally approved to treat patients with Duchenne muscular dystrophy (DMD) 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). tag:www.gov.uk,2005:/government/news/delgocitinib-approved-to-treat-adult-patients-with-severe-chronic-hand-eczema 2024-12-10T17:16:35+00:00 Delgocitinib approved to treat adult patients with moderate to severe chronic hand eczema 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.