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 European Union, and updates on EU marketing authorization changes recommended by the CHMP.
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The European Medicines Agency had a busy time at its meeting last week. It gave the green light to 11 products, four of which are for rare diseases including ANCA-associated vasculitis, and to a range of treatments for conditions as diverse as non-small cell lung cancer, smallpox, migraine, COPD, COVID-19 and obesity.
Nearly a year and a half after it was filed for approval, the EU regulator has rejected a mystery injectable product containing the monoclonal antibody bevacizumab for ophthalmic use.
Orphan drugs and COVID-19 products are among the latest filings under review by the European Medicines Agency for potential pan-EU approval.