European Performance Tracker
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.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Recommendations by the European Medicines Agency’s human medicines committee (the CHMP) on the authorization of new medicines in the EU and updates on marketing authorization changes recommended by the CHMP. Updated monthly.
Products containing new active substances that have been approved for marketing in the EU under the EU’s centralized authorization procedure. Updated monthly.
Decisions on sponsor requests for accelerated assessment of planned EU marketing authorization applications that will be reviewed by the European Medicines Agency’s human medicines committee (the CHMP) as well as information on whether MAAs granted accelerated assessment retain fast-track status as they make their way through the EU centralized procedure. Updated monthly.
New biosimilar product filings for review by the European Medicines Agency’s human medicines committee (the CHMP), CHMP opinions, withdrawals of applications and decisions on biosimilar marketing authorizations by the European Commission. Updated monthly.
A list of products that have been accepted onto the PRIME (priority medicines) scheme, the European Medicines Agency’s initiative for helping to speed up the development and regulatory review of promising medicines for unmet medical needs. The list is 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
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.
Sepiapterin, PTC Therapeutics' treatment for hyperphenylalaninemia in adult and pediatric patients with phenylketonuria, 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 three new products, including Qalsody, Biogen's treatment for amyotrophic lateral sclerosis associated with a mutation in the superoxide dismutase 1 gene.
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.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add three new products, including Zynyz, Incyte's treatment for Merkel cell carcinoma.
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.