First Oral Treatment For Spinal Muscular Atrophy Gets EMA Nod
Two Of Six Drugs Recommended For EU-Wide Use Have Orphan Designation
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.
Coronavirus Notebook: EU Moots Emergency Use Authorization Scheme For Vaccines, Janssen Product Up For 11 March Approval
Celltrion’s regdanvimab is undergoing an emergency use procedure in Europe, the European Medicines Agency and the health authorities in Canada have jointly published clinical data on the Moderna vaccine, and Canada has approved two versions of the AstraZeneca/Oxford University jab.
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.