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First Oral Treatment For Spinal Muscular Atrophy Gets EMA Nod

Two Of Six Drugs Recommended For EU-Wide Use Have Orphan Designation

Executive Summary

New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.

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One out of seven requests for the accelerated assessment of planned EU marketing authorization applications is known to have been granted this year to date.

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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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