EU CHMP Opinions and MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
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The European Medicines Agency said it was possible to use immunobridging studies to authorize COVID-19 vaccines now that a number of COVID-19 vaccines authorized in the EU are proven to be safe and effective and can be used as comparators in trials.
BridgeBio’s partner Helsinn terminated its agreement to commercialize infigratinib, which was approved in the US last year for treating the rare bile duct cancer, cholangiocarcinoma.
The European Medicines Agency has delivered its verdict on marketing applications for a raft of new medicines.