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EU CHMP

European Regulator Deals Blow For Lilly’s Alzheimer’s Drug Kisunla

Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.

Sponsors Of Two Orphans And An Acne Treatment To Defend Marketing Authorization Applications At EMA

Sponsors of three drugs that are in the final stages of the EU regulatory review cycle are due to make the case for marketing approval before the European Medicines Agency.

EU Marketing Approval Gap Between Lilly’s Donamemab and Eisai’s Leqembi Could Narrow

The European Medicines Agency is this week set to issue an opinion on whether pan-EU marketing should be granted to Lilly’s Alzheimer’s disease drug donanemab.

New EU Filings

Etuvetidigene autotemcel, Fondazione Telethon’s investigational gene therapy for Wiskott-Aldrich syndrome, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.

EU 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 EU, and updates on EU marketing authorization changes recommended by the 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.