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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.
The COVID-19 European Medicines Agency (EMA) pandemic Task Force (COVID-ETF) warned that chloroquine and hydroxychloroquine are yet to be proved effective at treating COVID-19 and that their side effects could be fatal.
Dr Roger Barker, University of Cambridge, UK and Eric Anthony, International Society for Stem Cell Research (ISSCR), describe how stem cells are regulated around the world and why this is important for patient safety.
Interim results from the SISCO study at the Papa Giovanni XXIII Hospital in Italy have demonstrated the promise of siltuximab as a treatment for the symptoms of COVID-19. Lee Morley explains how the drug works and the next steps for its development.
The COVID-19 EMA pandemic Task Force (COVID-ETF) will aid in the development, authorisation and safety monitoring of COVID-19 vaccines and therapeutics.
Marie Manley and co-authors from Sidley Austin explain the updates to regulations in the EU and UK in light of the COVID-19 coronavirus pandemic.
The European Medicines Agency (EMA) and other authorities have created a new shortage reporting system and are looking into how regulations can be applied more flexibly during the COVID-19 pandemic.
