European 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 European Union, and updates on EU marketing authorization changes recommended by the CHMP.
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The European Medicines Agency today revealed the names of the latest new products it believes should be approved for use across the EU.
The EU is set to be the first market to approve bluebird bio’s one-time gene therapy for cerebral adrenoleukodystrophy.
The sponsor of what could become the EU’s first approved ophthalmic formulation of bevacizumab needs to address outstanding issues raised by the European Medicines Agency about its filing.