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EU CHMP

New EU Filings

Elinzanetant, Bayer’s investigational treatment for hot flashes in menopausal women, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Advanz Pharma’s Ocaliva Loses EU Conditional Marketing Authorization

Advanz Pharma, the company that markets Ocaliva for primary biliary cholangitis in the EU, will continue to supply the drug on a compassionate use or named patient basis.

Why The EMA Said No To Kizfizo And Cinainu

The European Medicines Agency has recommended against EU marketing approval for two drugs targeting children.