News about "UK MHRA"

UK MHRA Approves Vyjuvek for Treatment of Dystrophic Epidermolysis Bullosa Wounds

Medicines and Healthcare products Regulatory Agency has approved Vyjuvek for treating wounds in patients with dystrophic epidermolysis bullosa, including newborns.

UK MHRA | 18/05/2026 | 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.

UK MHRA | 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.

UK MHRA | 15/04/2026 | By News Bureau |  130

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.

UK MHRA | 23/02/2026 | By News Bureau |  216

Akums Receives First UK MHRA Approval for Rivaroxaban

Rivaroxaban is an oral anticoagulant prescribed for the prevention and treatment of thromboembolic disorders, including Non-Valvular Atrial Fibrillation (NVAF), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE) and clinically relevant cardiovascular risk reduction.

UK MHRA | 10/02/2026 | By News Bureau |  164

UK MHRA Updates Safety Information on Semaglutide Over Rare NAION Vision Risk

UK MHRA flags a very rare risk of NAION linked to semaglutide, urging patients to seek immediate medical attention for sudden changes in vision.

UK MHRA | 07/02/2026 | By News Bureau |  568

Paracetamol Safe in Pregnancy, Confirms MHRA After Major Lancet Review Finds No Autism or ADHD Risk

The UK medicines regulator MHRA reaffirmed paracetamol as safe during pregnancy after a major Lancet review found no link to autism, ADHD or intellectual disability in children.

UK MHRA | 20/01/2026 | By News Bureau |  337

UK MHRA Approves up to 7.2 mg Dose of Semaglutide for Obesity Treatment

The UK MHRA has approved a higher dose of semaglutide of up to 7.2 mg for weight management in adult patients with obesity. The regimen involves three 2.4 mg injections and is indicated for use alongside a reduced-calorie diet and increased physical activity in adults with a Body Mass Index (BMI) of 30 kg/m² or higher.

UK MHRA | 17/01/2026 | By News Bureau |  143

Aurobindo Pharma Wins UK MHRA Approval for Dazublys Trastuzumab Biosimilar

CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its trastuzumab biosimilar, Dazublys, used in the treatment of HER2-positive breast and gastric cancers.

UK MHRA | 27/08/2025 | By Darshana |  262

Marksans Pharma announces UK MHRA approval for Fluoxetine 20mg/5ml oral solution

The product will be manufactured at the plant of Bell, Sons & Co, UK

UK MHRA | 24/01/2023 | By Sudeep Soparkar |  595