News about "UK MHRA"

UK MHRA Outlines Regulatory Framework for Microbiome-Based Medicines

The UK Medicines and Healthcare products Regulatory Agency (MHRA) publishes a position paper outlining the UK licensing route for microbiome-based medicines, helping developers advance innovative therapies to patients.

UK MHRA | 19/08/2026 | By News Bureau

UK MHRA Approves Vimseltinib for Tenosynovial Giant Cell Tumours

UK MHRA approves Deciphera Pharma’s vimseltinib for adults with tenosynovial giant cell tumours affecting movement or where surgery is not an option.

UK MHRA | 18/08/2026 | By News Bureau

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.

UK MHRA | 23/07/2026 | By News Bureau

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 |  107

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 |  115

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 |  141

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 |  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.

UK MHRA | 15/04/2026 | By News Bureau |  200