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EMA recommends 11 new medicines for approval following July meeting europeanpharmaceuticalreview
July 28, 2020
Dapivirine Vaginal Ring (dapivirine) and Blenrep (belantamab mafodotin) have been recommended for approval by the EMA’s CHMP, along with nine other medicines.
EMA to monitor real world use of COVID-19 treatments and vaccines europeanpharmaceuticalreview
July 24, 2020
The EMA has built up an infrastructure to allow for the monitoring of COVID-19 treatments and vaccines used in clinical practice.
EMA issues opinion on nitrosamines in medicines europeanpharmaceuticalreview
July 14, 2020
The agency’s opinion will require companies to take measures to reduce nitrosamine impurities in medicines and carry out and action the results of risk assessments.
EMA finalises opinion on presence of nitrosamines in medicines expresspharma
July 13, 2020
Companies will be required to have appropriate control strategies to prevent or limit the presence of these impurities and, where necessary, improve their manufacturing processes.
EMA recommends Idefirix (imlinfidase) is granted marketing authorisation europeanpharmaceuticalreview
July 03, 2020
The European Medicines Agency (EMA) recommended Idefirix is granted conditional marketing authorisation for highly sensitised patients awaiting kidney transplant.
Emer Cooke nominated as new EMA Executive Director expresspharma
June 28, 2020
Emer Cooke is currently the Director of the Regulation and Prequalification Department at the World Health Organization (WHO) in Geneva.
EMA recommends authorisation for remdesivir to combat COVID-19 europeanpharmaceuticalreview
June 28, 2020
The EMA’s human medicines committee (CHMP) has recommended a conditional marketing authorisation for Veklury (remdesivir) to treat COVID-19.
EMA to consider expanding use of Merck/Pfizer's Bavencio pharmatimes
June 23, 2020
The European Medicines Agency has validated for review Merck and Pfizer's application to market Bavencio (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC).
Safe and effective vaccination should be given high priority: EMA expresspharma
June 19, 2020
The two ICMRA statements aim to reassure healthcare professionals and the public around the globe that medicines regulators only allow vaccines onto the market that fulfil the highest standards of safety, efficacy and quality.
AbbVie Submits Regulatory Applications to FDA, EMA for Psoriatic Arthritis Treatment americanpharmaceuticalreview
June 15, 2020
AbbVie has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for RINVOQ™ (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor ...

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