European Union

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.

EU Legislation and Regulatory Notices - February 27, 2026

The EU published its Official Journal L series for February 27, 2026, containing various legislative and non-legislative acts. These include decisions on international trade agreements with Mercosur and new delegated regulations concerning liquidity management tools for investment funds and market data for equity instruments.

ESMA Supervisory Briefing on Algorithmic Trading

The European Securities and Markets Authority (ESMA) has issued a supervisory briefing to support consistent supervision of algorithmic trading across the EU. The briefing provides National Competent Authorities with tools and clarified expectations for supervising firms engaged in algorithmic trading under MiFID II, including considerations for AI.

ESMA Consults on EMIR 3 Post-Trade Risk Reduction Services

The European Securities and Markets Authority (ESMA) has launched a consultation on the requirements for post-trade risk reduction (PTRR) services under EMIR 3. The consultation seeks feedback on draft Regulatory Technical Standards (RTS) that define conditions for PTRR services to benefit from a clearing obligation exemption.

EDPB Opinion on Dutch Authority's Draft Decision for Arcadis Group

The European Data Protection Board (EDPB) has issued an opinion on a draft decision by the Dutch Data Protection Authority concerning Arcadis Group's Binding Corporate Rules (BCRs). This opinion addresses the international transfer of data and the adequacy of the BCRs.

EDPB Opinion on ABN AMRO Binding Corporate Rules

The European Data Protection Board (EDPB) has issued Opinion 06/2026 regarding the Binding Corporate Rules (BCRs) of ABN AMRO. This opinion addresses the draft decision from the Dutch supervisory authority concerning these BCRs.

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.