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European Performance Tracker
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Analysis
Pink Sheet Podcast Special: Why The US Approves Most New Drugs Before The EU
By Pink Sheet TeamPink 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.
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Data
New EU Filings
By Neena BrizmohunZanidatamab, 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.
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News
New EU Approvals
By Neena BrizmohunThe 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
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News
EU CHMP Opinions And MAA Updates
By Neena BrizmohunThis 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.
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Data
New EU Filings
By Neena BrizmohunSepiapterin, 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.
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News
New EU Approvals
By Neena BrizmohunThe 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.
![](/-/media/editorial/pink-sheet/00_regular-column-images/eu_chmp_opinions_1401450965_1200.jpg?rev=00673ea88e184380a0910a4af4154876&w=350&hash=D9D55BEF36EB3DD6105D2E8FACC44C49)
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News
EU CHMP Opinions And MAA Updates
By Neena BrizmohunThis 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.
![](/-/media/editorial/pink-sheet/00_regular-column-images/ps2407_new_eu_approvals_2112650408_1200.jpg?rev=65419f4fe56f4d24bc7223dd338dd3df&w=350&hash=DCC7F78E80AACED864241137D1F64FF5)
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News
New EU Approvals
By Neena BrizmohunThe 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.
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Data
EU Biosimilar Filings, Opinions And Approvals
By Ian SchofieldA 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.
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