Diurnal Renames Orphan Drug As Efmody, Expecting EU-Wide Approval
EMA Also OKs Novel Contraceptive With Blockbuster Potential
Executive Summary
New treatments for congenital adrenal hyperplasia and relapsing forms of multiple sclerosis are among five drugs recommended for pan-EU approval this month. In addition, harmonized EU advice has been issued for Celltrion’s monoclonal antibody COVID-19 treatment.
You may also be interested in...
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.
Pivotal Moment In EU For Potential New Drugs
Decisions are due on several EU marketing applications at the March meeting of the European Medicines Agency’s drug evaluation committee, the CHMP. Also, a number of companies might be asked to address outstanding issues the CHMP has about products they want to market that are near the final stages of review.
Regulators Decide On EU Marketing For 'Game-Changing' Contraceptive
Mithra’s combined oral contraceptive Estelle includes estetrol, the first compound in the contraceptive area to be designated a new active substance in Europe in over 80 years.