EMA News

Virtual Control Groups to Reduce Animal Testing in Medicines Development

EMA's CHMP has issued a draft qualification opinion for virtual control groups (VCG) to replace concurrent animal control groups in rat dose-range finding studies. The consultation runs from 31 March to 12 May 2026, inviting comments from the scientific community and stakeholders on this new approach methodology (NAM).

EMA Recommends Imdylltra for Relapsed Small Cell Lung Cancer

The European Medicines Agency (EMA) has recommended marketing authorisation for Imdylltra (tarlatamab) for adults with relapsed extensive-stage small cell lung cancer. This recommendation is based on Phase 3 trial data showing improved overall survival and progression-free survival compared to standard of care.

EMA Recommends Restricting Tecovirimat SIGA for Mpox Treatment

The EMA's Committee for Human Medicines has recommended restricting the use of Tecovirimat SIGA for the treatment of mpox. Clinical trials showed the medicine was not effective in healing lesions faster than placebo in mpox patients with active lesions. This recommendation does not affect other authorised uses of Tecovirimat SIGA.

EMA Enhances PRIME Scheme to Accelerate Medicine Development

The European Medicines Agency (EMA) has launched three new features for its PRIME scheme, designed to accelerate the development of medicines targeting unmet medical needs. These tools aim to streamline scientific dialogue and provide developers with faster answers and better preparation for marketing authorisation applications.

EMA Draft Guidance on Clinical Trials During Public Health Emergencies

The European Medicines Agency (EMA) has published draft guidance for conducting clinical trials during public health emergencies.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.

CVMP Opinions and Guidelines Update

The EMA's Committee for Veterinary Medicinal Products (CVMP) adopted positive opinions for several variations to existing veterinary medicinal products and discussed pharmacovigilance signals. These updates primarily involve product information changes based on signal management processes.