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 UK drug regulator, the MHRA, has approved its first product under Project Orbis, the US-led international regulatory collaboration scheme it joined four months ago to speed up access to promising cancer medicines.
The European Medicines Agency today announced the new medicines it believes should be approved for use across the EU.
Leo’s moderate-to-severe atopic dermatitis drug is set to be approved for the first time worldwide.