Four Orphan Drugs Get EU Approval Recommendation
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.
You may also be interested in...
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.
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.
The European Commission is likely to act rapidly on the formal approval of coronavirus treatments casirivimab/imdevimab and regdanvimab.