News about "Medicines and Healthcare Products Regulatory Agenc"

Chiesi Secures UK Approval for World's First Low-Carbon pMDIs Using Next-Generation Propellant

MHRA authorises Clenil Modulite inhalers with a non-PFAS, low global warming potential propellant, reducing carbon emissions by up to 90 percent while maintaining therapeutic efficacy.

Medicines And Healthcare Products Regulatory Agenc | 23/07/2026 | By News Bureau

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 |  102

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 |  113

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 |  120

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 |  200

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 |  272

Medicines and Healthcare products Regulatory Agency Approves Inluriyo for Advanced ER-Positive Breast Cancer

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 |  218

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 |  608