News about "UK MHRA"

Jascayd (Nerandomilast) Wins UK MHRA Approval for Pulmonary Fibrosis Treatment

Nerandomilast (Jascayd) has been approved for adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), expanding treatment options for these chronic lung diseases.

UK MHRA | 09/07/2026 | By News Bureau

UK MHRA Approves Retifanlimab for Merkel Cell Skin Cancer

The UK MHRA has approved retifanlimab (ZYNYZ) for the treatment of advanced Merkel Cell Carcinoma (MCC), a rare and aggressive skin cancer with significant unmet medical need.

UK MHRA | 08/07/2026 | By Akanki

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.

UK MHRA | 01/07/2026 | By News Bureau

UK MHRA Approves Rilzabrutinib for Adults with Immune Thrombocytopenia

Rilzabrutinib has been authorised in the UK for the treatment of adults with immune thrombocytopenia who have had an insufficient response to previous therapies, providing a new treatment option for this rare autoimmune bleeding disorder. The UK MHRA will continue to closely monitor the medicine’s safety and effectiveness following approval.

UK MHRA | 01/06/2026 | By News Bureau

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 |  166

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 |  235

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 |  175

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 |  604