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Earlier this year, Johnson & Johnson announced the first major regulatory approval of a vaccine developed by Janssen for the prevention of Ebola. Nikki Withers spoke with the Global Head of Vaccines, Johan Van Hoof, to discover what technologies were used and how they are now being leveraged to develop…
The European Commission has granted marketing authorisation to Celltrion's Remsima (infliximab, CT-P13) subcutaneous formulation.
The EMA has begun to review dexamethasone to provide an opinion on the results of the RECOVERY study for the treatment of adults admitted to hospital with COVID-19.
Dapivirine Vaginal Ring (dapivirine) and Blenrep (belantamab mafodotin) have been recommended for approval by the EMA's CHMP, along with nine other medicines.
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.
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.
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.
The COVID-19 EMA pandemic Task Force (COVID-ETF) will aid in the development, authorisation and safety monitoring of COVID-19 vaccines and therapeutics.
