EMA

EMA PRAC Warns of Aseptic Meningitis Risk with Ixchiq Vaccine

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended updating the product information for the chikungunya vaccine Ixchiq to reflect recent evidence of aseptic meningitis risk, particularly in healthy young adults. This follows a safety signal investigation and is part of a regular safety assessment.

EMA CHMP Meeting Agenda February 2026

The European Medicines Agency (EMA) has published the draft agenda for the Committee for Medicinal Products for Human Use (CHMP) meeting scheduled for February 23-26, 2026. The agenda outlines topics for discussion, including pre-authorisation and post-authorisation procedures for various medicinal products.

EMA CHMP Meeting Minutes July 2025

The European Medicines Agency (EMA) has published the minutes from the Committee for Medicinal Products for Human Use (CHMP) meeting held from July 21-24, 2025. The document details discussions and opinions on various medicinal products, including initial applications and re-examinations.

EMA Draft Guidance on Clinical Trials During Public Health Emergencies

The European Medicines Agency (EMA) has published draft guidance for conducting clinical trials during public health emergencies. This guidance, open for consultation until April 30, 2026, aims to streamline the authorization of new trials and modifications to ongoing trials.

EMA Recommends Ojemda for Paediatric Low-Grade Glioma

The European Medicines Agency (EMA) has recommended a conditional marketing authorisation for Ojemda (tovorafenib) to treat paediatric low-grade glioma in patients aged 6 months and older with specific BRAF gene alterations. This recommendation addresses an unmet medical need for a targeted therapy in this patient population.

EMA CHMP Recommends 12 Medicines for Approval

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended 12 new medicines for approval and six for extension of therapeutic indications. This includes novel treatments for influenza, COVID-19, paediatric brain tumours, Parkinson's disease, and several biosimilar medicines.

EMA Recommends Six New Medicines for Approval

The European Medicines Agency's CHMP has recommended six new medicines for marketing authorisation and nine for extension of therapeutic indications. These recommendations cover treatments for various conditions including menopausal symptoms, liver disease, a rare genetic disorder, influenza, and graft-versus-host disease.

EMA Recommends Kygevvi for Rare TK2d Disease Treatment

The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Kygevvi, a new treatment for the rare genetic disease thymidine kinase 2 deficiency (TK2d). This recommendation is based on clinical study data showing improvement in motor function for pediatric patients.

EMA Recommends Withdrawal of Levamisole Medicines

The European Medicines Agency (EMA) recommends the withdrawal of marketing authorisations for medicines containing levamisole due to the serious side effect of leukoencephalopathy. This recommendation follows an EU-wide review concluding that the benefits of these medicines no longer outweigh their risks for treating parasitic worm infections.

Levamisole withdrawn from EU market due to leukoencephalopathy risk

The EMA's PRAC has recommended the withdrawal of marketing authorisations for all medicines containing levamisole from the EU market. This decision is due to the confirmed risk of leukoencephalopathy, a serious brain side effect, where the benefits of the medicine no longer outweigh the risks for treating parasitic worm infections.