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Pink Sheet Podcast Special: Why The US Approves Most New Drugs Before The EU

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.

Regional Comparisons Approvals

New EU Filings

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.

Drug Review Europe

New EU Approvals

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

Europe Approvals

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.

European Performance Tracker Drug Review

New EU Filings

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.

Drug Review Europe

New EU Approvals

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.

Europe Approvals

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.

Drug Review Europe

New EU Approvals

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.

Europe Approvals

EU Biosimilar Filings, Opinions And Approvals

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.

Europe Approvals
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