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The European Medicines Agency (EMA) recommended Idefirix is granted conditional marketing authorisation for highly sensitised patients awaiting kidney transplant.
The European Medicines Agency's human medicines committee (CHMP) said the treatment would offer a therapeutic option for certain cystic fibrosis phenotypes that are currently untreatable.
This article delves into four health technology assessment agencies, analysing the opportunities and challenges for orphan drugs in France, Germany, England and Scotland.
The EMA's human medicines committee (CHMP) has recommended a conditional marketing authorisation for Veklury (remdesivir) to treat COVID-19.
After nitrosamines were detected in sartan medicines, the EMA has released new recommendations about handling and reporting impurities in drugs.
The European Medicines Agency (EMA) said its assessment of the conditional marketing authorisation (CMA) application will be performed under a reduced timeframe, with a decision potentially delivered in weeks.
Developed by Janssen, the two-dose regimen has already been given to 60,000 patients and now has the positive opinion of the Committee for Medicinal Products for Human Use (CHMP).
The research will identify sources of data to monitor coverage and effectiveness, and support pharmacovigilance of COVID-19 vaccines once they are approved.
The EMA has suggested that the safety information be updated for HRT, to reflect a higher risk of breast cancer and recommends new measures for the handling of leuprorelin depot medicines.
Heidi West discusses how academia, government and the pharmaceutical industry can work together to potentially repurpose drugs for the treatment of COVID-19.
The EMA has announced new regulatory changes that will help potential COVID-19 vaccines and therapeutics accelerate through development.
The EMA's human medicines committee has announced it has begun a rolling review of remdesivir for the treatment of COVID-19, to examine its safety and effectiveness.
The EMA's human medicines committee has adopted a positive opinion for eight medicines, recommending their marketing authorisation.
The EMA has announced its support for the International Coalition of Medicines Regulatory Authorities' call for global collaboration in the fight against COVID-19.