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24d ago ESMA News
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ESMA Publishes Annual Equity Transparency Calculations

The European Securities and Markets Authority (ESMA) has published its annual transparency calculations for equity and equity-like instruments, effective April 6, 2026. These calculations determine liquidity assessments, relevant markets, large-in-scale thresholds, and tick-size regimes.

Priority review Guidance Securities
24d ago EMA News
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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.

Priority review Guidance Pharmaceuticals
24d ago EMA News
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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.

Priority review Notice Pharmaceuticals
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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.

Routine Notice International Trade
25d ago ESMA News
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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.

Priority review Consultation Securities
25d ago ESMA News
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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.

Priority review Guidance Securities
25d ago EDPB Documents (GDPR)
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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.

Routine Guidance Data Privacy
25d ago EDPB Documents (GDPR)
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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.

Priority review Guidance Data Privacy
26d ago EMA News
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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.

Priority review Notice Pharmaceuticals
26d ago EMA News
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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.

Priority review Guidance Pharmaceuticals

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