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.
You may also be interested in...
Coming year could feature first-time approvals in the EU for at least five gene therapies.
The European Medicines Agency has recommended that the therapeutic indications of Keytruda and Bavencio should be expanded again.
The therapeutic indication of Spravato is set to be expanded in the EU after receiving the thumbs up from the European Medicines Agency. The nasal spray has been shown to reduce depressive symptoms in just four hours and would fill a key unmet need, says the drug’s developer, Janssen.