EMA Greenlights Ronapreve & Regkirona For COVID-19 In EU
The European Commission is likely to act rapidly on the formal approval of coronavirus treatments casirivimab/imdevimab and regdanvimab.
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Orphan drugs and COVID-19 products are among the latest filings under review by the European Medicines Agency for potential pan-EU approval.
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.