EMA confirms Mangoral eligible for the centralized regulatory procedure in the EU
Ascelia Pharma AB (publ) (ticker: ACE) today announced that it has received confirmation from the European Medicines Agency (EMA) that a Marketing Authorization Application (MAA) for Mangoral is eligible to be submitted in the European Union (EU) under the Agency’s centralized procedure. Mangoral is Ascelia Pharma’s lead drug candidate, currently in Phase 3 development.The centralized procedure permits the submission of a single marketing application to the EMA that, if approved, allows the drug to be marketed in all EU member states, rather than requiring independent national procedures.