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Executive Summary
The European Medicines Agency has cleared the decks for the pan-EU approval of nearly a dozen new drugs. Tecvayli is headed for a conditional approval, while Nulibry is slated to get marketing authorization under exceptional circumstances.
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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.
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.