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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...
NewsHumanMedicines
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.
NewsHumanMedicines
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.
NewsHumanMedicinesPaediatrics
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.
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EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2023 meeting.
NewsHumanMedicinesReferrals
The European Commission (EC), the Heads of Medicines Agencies (HMA) and EMA have published the first version of the Union list of critical medicines. It contains more than 200 active substances of medicines for human use considered critical for healthcare systems across the EU/EEA, for which continuity of supply is a priority and shortages should...
NewsHumanMedicine shortages
The Committee adopted by consensus a positive opinion for a variation requiring assessment for Bravecto (fluralaner) concerning the addition of a new pharmaceutical form, 150 mg/ml powder and solvent for suspension for injection, for dogs.
NewsVeterinaryMedicines
Close collaboration between medicines regulators worldwide is paving the way towards the development of a global Pharmaceutical Quality Knowledge Management System (PQ KMS). The goal is to ensure patients can benefit from a continuous supply of life-saving medicines in a world where changing manufacturing processes, technological innovations and...
NewsHumanMedicines
EMA has relaunched its website: www.ema.europa.eu. The new website, with a refreshed overall look and feel, aims to help users find the information they need more easily.
NewsCorporate
The European Medicines Regulatory Network (EMRN) has been at the forefront of the fight against COVID-19 with its crucial role in the evaluation and monitoring of medicines, including vaccines. A joint report issued by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) reviews the Network’s response and highlights the...
NewsHumanCOVID-19