European Performance Tracker

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add four new products, including Anzupgo, LEO Pharma's treatment for moderate to severe chronic hand eczema in adults for whom topical corticosteroids are inadequate or inappropriate.

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.

Pridopidine, Prilenia Therapeutics’ investigational treatment for Huntington’s disease, is among the latest products that the European Medicines Agency has started reviewing for potential pan-EU marketing authorization.

Products containing new active substances that have been approved for marketing in the EU under the EU’s centralized authorization procedure. Updated monthly.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add seven new products, including Winrevair, MSD's treatment for pulmonary arterial hypertension.

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

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.

Pink Sheet reporter and editors discuss the impact of a US and EU drug approvals analysis that found the US FDA still clears many novel products first, including most new cell and gene therapies and cancer treatments.

Zanidatamab, Jazz and BeiGene’s investigational treatment for biliary tract cancer, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, including Ixchiq, Valneva's chikungunya virus vaccine