European Medicine Agency

Health news

EU regulator backs new Alzheimer’s drug, months after rejecting it

An expert committee recommended that the drug be offered to a narrow group of patients with early-stage Alzheimer’s disease.

25/07/2025

Health news

EU regulators back twice-yearly HIV injection

The drug is expected to be formally approved by the European Commission this year.

25/07/2025

Health news

Hair loss drug linked to risk of suicidal thoughts, EU regulator says

The medicine will remain on the shelves but will come with additional warnings about the side effects, which appear to be rare.

08/05/2025

Health news

Agency flags risks to nuclear medicines from dependency on Russia, US

Raw material dependency and transport bottlenecks, not just production capacity, are the key challenges facing the EU's radiopharmaceutical sector, according to the European Medicines Agency (EMA).

15/04/2025

Health news

EU regulators block new Alzheimer’s drug over side effects

The company behind the drug donanemab said it will ask regulators to reconsider the decision.

28/03/2025

Healthcare

Beware of unproven cancer treatments, EU medicine regulators say

The warning comes amid reports that unregulated therapies are being offered directly to patients, potentially illegally.

20/03/2025

EuroVerify

The EMA has not 'admitted' that mRNA vaccines are 'experimental'

False claims about vaccines, specifically COVID vaccines, continue to do the rounds online.

28/02/2025

Healthcare

Europe launches medicine shortage monitoring in 2025

Among the health policy novelties of 2025, a new tool developed by the European Medicines Agency (EMA) is set to harmonise monitoring of medicine shortages across Europe.

08/01/2025

Health news

European regulators approve new Alzheimer's drug after rejecting it

European regulators initially said in July that the drug's benefits did not outweigh its risks.

15/11/2024

Health news

EU Court halts Commission’s ban on drug for rare liver disease

In an unusual turn of events, the EU's top court has temporarily suspended the European Commission's decision to revoke the marketing authorisation for a drug used to treat the rare autoimmune liver disease.

06/09/2024

Health news

This nasal spray can treat allergy patients with severe reactions

The nasal spray was approved in the US and has been recommended for approval by EU regulators.

16/08/2024

Healthcare

Patients rally against EU ban on autoimmune drug

Protestors want the European Commission to ignore official advice and keep marketing authorisation for drugs used to treat a rare liver disease.

26/07/2024

Health news

ALS drug removed from US market after trial shows it doesn't work

A pharmaceutical company announced its intention to remove a drug for ALS from the US and Canadian markets after a trial showed it did not work.

05/04/2024

Health news

Agency chief seeks help from pharma industry with medicines shortages

Greater transparency between regulators and manufacturers can foster a better understanding of supply chain vulnerabilities and reduce risks of drug shortages, European Medicines Agency (EMA) Executive Director Emer Cooke told Euronews in an interview.

04/04/2024

Health news

€2.5 million drug now approved in Ireland, Belgium and the Netherlands

Libmeldy - a treatment for a rare disease costing €2.5 million - has become available in Ireland, Belgium and the Netherlands.

26/01/2024

Healthcare

MEPs call on Commission to foot medicines agency’s Brexit shortfall

A forced relocation and the collapse of hotdesking company WeWork could leave the formerly London-based regulator with a €30 million budget hole for 2024.

12/01/2024

Healthcare

France debates amendment on biomedicine substitution in pharmacies

An amendment is being debated on whether pharmacies can substitute approved replacements for biological medicines, but patient organisations have raised concerns.

15/11/2023

Health news

Fake Ozempic pens identified in European countries, EU regulators warn

Ozempic is a diabetes medicine that has been in high demand.

19/10/2023

Health news

EU regulators back authorisation of first RSV vaccine for infants

RSV is a common respiratory virus that causes cold-like symptoms but can cause serious illness in children and older adults.

21/07/2023

World News

European Medicines Agency COVID-19 warning

The European Medicines Agency warns that the pandemic is not over and that it expects a new wave of COVID-19 infections to start within a week

26/10/2022