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Europe Approvals Regulation

AstraZeneca/Daiichi Sankyo’s Enhertu To Get Lung Cancer Label For EU

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Executive Summary

The European Medicines Agency has recommended new uses for 11 approved medicines, including an antibody drug conjugate for treating advanced non-small cell lung cancer.

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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.

Lebrikizumab Among Nine Drugs To Get EMA Nod; PTC Faces Disappointment For Translarna

The European Medicines Agency has OKd nine new medicines for EU-wide approval, but recommended against renewing the conditional marketing authorization of two drugs. 

EU Advances Plans For New Catalogs Of RWD Sources & Non-Interventional Studies

Users of the new catalogs will benefit from a modern technology with enhanced view, search, export and data submission functionalities, says the European Commission.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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