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.
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Estetrol Approvals Mark 'Turning Point' For Mithra
Recent Canadian, European and US endorsements of Mithra’s estetrol-based Estelle novel oral contraceptive mark a “turning point” for the Belgian firm, which has also seen success with its Myring generic rival to NuvaRing for which it expects to see further launches this year.
Diurnal Renames Orphan Drug As Efmody, Expecting EU-Wide Approval
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.
EU Crunch Time For Diurnal’s Potentially 'Transformational' Rare Disease Drug
The European Medicines Agency is deciding on the EU marketing application for Chronocort, a life-long treatment for congenital adrenal hyperplasia.