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The midterm report of the European Medicines Agencies Network Strategy (EMANS) finds the pandemic strengthened the network and supported transformative change in the European system across key strategic areas.
News
Corporate
The European Medicines Agency's (EMA) office is closed from 18:30 on Friday 22 December 2023 to 07:30 on Wednesday 3 January 2024.
News
Corporate
EMA's Executive Director, Emer Cooke, shares her end-of-year message and takes stock of EMA's work in 2023.
News
Corporate
EMA and the Heads of Medicines Agencies (HMAs) have published an artificial intelligence (AI) workplan to 2028, setting out a collaborative and coordinated strategy to maximise the benefits of AI to stakeholders while managing the risks.
News
Corporate
Data on medicines
The Board adopted EMA’s work programme for 2024, acknowledging that the Agency will continue to deliver on all its strategic priorities.
News
Human
Veterinary
Corporate
EMA has recommended approval of the first medicine using CRISPR/Cas9, a novel gene-editing technology. Casgevy (exagamglogene autotemcel) is indicated for the treatment of transfusion‑dependent beta thalassemia and severe sickle cell disease in patients 12 years of age and older for whom haematopoietic stem cell transplantation is appropriate and a...
News
Human
Medicines
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2023 meeting.
News
Human
Medicines
Referrals
EMA’s human medicines committee (CHMP) has adopted a positive scientific opinion for Arpraziquantel used to treat schistosomiasis in young children aged 3 months to 6 years.
News
Human
Medicines
Paediatrics
EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorisations of a number of generic medicines tested by Synapse Labs Pvt. Ltd, a contract research organisation (CRO) located in Pune, India.
News
EMA’s human medicines committee (CHMP) has confirmed its initial recommendation to not renew the conditional marketing authorisation for Blenrep (belantamab mafodotin) because recent data did not confirm its effectiveness; the benefits of Blenrep are therefore considered to no longer outweigh its risks.
News
Human
Medicines