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News about "Medicines and Healthcare Products Regulatory Agenc"
MHRA Approves Use of UK-Donor Plasma for Five Additional Life-Saving Medicines
The UK's Medicines and Healthcare products Regulatory Agency has approved the use of UK-donor plasma for producing five additional plasma-derived medicines after determining that the risk of variant Creutzfeldt-Jakob disease (vCJD) transmission is negligible. The decision is expected to improve the resilience of the UK's plasma medicine supply chain.
Medicines And Healthcare Products Regulatory Agenc | 10/07/2026 | By News Bureau
UK MHRA Approves Wegovy for Treatment of MASH in Adults with Liver Fibrosis
The UK's Medicines and Healthcare products Regulatory Agency has conditionally approved Novo Nordisk's Wegovy (semaglutide) for treating metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced liver fibrosis, subject to ongoing confirmatory clinical data.
Medicines And Healthcare Products Regulatory Agenc | 06/07/2026 | By News Bureau
Eisai seeks UK Approval for Insomnia Therapy Lemborexant
Eisai has submitted lemborexant for regulatory review in the UK, aiming to expand treatment options for adults suffering from chronic insomnia and improve patients' daytime functioning.
Medicines And Healthcare Products Regulatory Agenc | 04/07/2026 | By News Bureau
Nuvation Bio's Taletrectinib Advances UK Regulatory Review for ROS1-Positive Lung Cancer
The UK's MHRA has validated the marketing application for Nuvation Bio's taletrectinib, bringing the next-generation ROS1 inhibitor one step closer to approval for patients with advanced ROS1-positive non-small cell lung cancer in the UK.
Medicines And Healthcare Products Regulatory Agenc | 01/07/2026 | By News Bureau
UK MHRA Approves Linerixibat (Lynavoy) for Biliary Disease Itch
The UK Medicines and Healthcare products Regulatory Agency (MHRA) approves linerixibat (lynavoy) for treating itch associated with biliary tract disease, with ongoing monitoring of safety and effectiveness.
Medicines And Healthcare Products Regulatory Agenc | 04/05/2026 | By News Bureau
UK MHRA Approves Single-Dose 7.2mg Wegovy Injection for Obesity Treatment
The UK Medicines and Healthcare products Regulatory Agency has approved a single-dose 7.2mg Wegovy pen, simplifying weekly treatment for adults with obesity and a BMI of 30 or higher.
Medicines And Healthcare Products Regulatory Agenc | 15/04/2026 | By News Bureau | 166
UK MHRA Secures EUro 3.6 Million to Expand AI Airlock for Safer Medical AI Innovation
Backed by multi-year government funding, the UK’s first AI medical device regulatory sandbox will scale real-world testing, strengthen oversight and accelerate safe adoption of clinical AI technologies.
Medicines And Healthcare Products Regulatory Agenc | 09/04/2026 | By News Bureau | 249
The UK regulator has approved Inluriyo (imlunestrant tosylate) for adults with ER-positive, HER2-negative advanced breast cancer with ESR1 mutations after prior hormone therapy failure.
Medicines And Healthcare Products Regulatory Agenc | 26/02/2026 | By News Bureau | 180
MHRA Approves Brensocatib as First Targeted Treatment for Non-Cystic Fibrosis Bronchiectasis in UK
UK regulator grants marketing authorisation to brensocatib (Brinsupri) for patients aged 12 and above with recurrent non-cystic fibrosis bronchiectasis flare-ups.
Medicines And Healthcare Products Regulatory Agenc | 24/02/2026 | By News Bureau | 482
CStone Pharmaceuticals Secures UK MHRA Approval for Sugemalimab in Stage III NSCLC
The UK Medicines and Healthcare products Regulatory Agency grants a new indication for sugemalimab monotherapy in unresectable Stage III NSCLC, expanding its European footprint and global commercial reach.
Medicines And Healthcare Products Regulatory Agenc | 23/02/2026 | By News Bureau | 235
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