Latest European Medicines Agency News & Updates

See the latest news and media coverage for EMA. We track all announcements, press releases, and industry mentions in real time, all in one place.

European Medicines Agency (EMA)

European Union medicines regulatory agency

ema.europa.eu

Headquarters: Amsterdam, Netherlands
Founded year: 1995
Company type: Government agency
Number of employees: 500–1,800
Industry: Government & Government Finance

Last updated Today

Latest news about European Medicines Agency (EMA)

In short: EMA authorized Nezglyal for cALD and Wegovy pill, advanced biosimilars, and set AI principles with FDA while reviewing drug safety.

Company announcements

September 24 EMA

EMA releases new CTIS safety module guidance

The document details the New Safety Module for Annual Safety Reports, integrated into CTIS in October 2026.

September 24 EMA

EMA authorises Nezglyal for cerebral adrenoleukodystrophy treatment

The medicine leriglitazone is authorized for boys aged two to twelve with early-stage disease under exceptional circumstances following a positive committee opinion.

September 24 EMA

EMA authorizes Ruxolitinib Viatris in the EU on September 18

This generic medicine treats myelofibrosis, polycythaemia vera, and acute or chronic graft-versus-host disease in adults and children. Its benefits were assessed as outweighing risks based on bioequivalence to Jakavi.

September 22 EMA

EMA authorizes Zokovea for COVID-19 prevention

The medicine containing ensitrelvir receives EU marketing authorization for post-exposure prophylaxis in individuals over twelve years old.

Media coverage

Yesterday Pharmaceutical Technology

EMA Aims to Facilitate Biosimilars Development | Pharmaceutical Technology

The European Medicines Agency has updated its guidance on biosimilar medicines, with the aim of helping companies to avoid unnecessary repetition of clinical trials.

Yesterday Ad hoc news

Novo Nordisk Spends Big on Monthly Shots While EMA Backs Two New Therapies

Novo Nordisk pays up to EUR 1.17B for monthly-shot tech and gains two EMA nods, but shares stay muted as Lilly leads US GLP-1 market...

February 27 Newswire

European Medicines Agency's Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Marketing Authorization of mCOMBRIAX, Moderna's mRNA Combination ...

mCOMBRIAX is the world's first flu plus COVID combination vaccine to receive a positive CHMP opinion recommending marketing authorization and represents Moderna's fourth vaccine to...

9 December 2020 BBC

Pfizer/BioNTech vaccine docs hacked from European Medicines Agency

The European Medicines Agency (EMA) says it has been hit by a cyber-attack and documents relating to a Covid-19 vaccine have been accessed.

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