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Europe Drug Review Approvals

Orphan Drugs Dominate Latest EU Filings

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Executive Summary

Sotatercept, marstacimab, elafibranor, eplontersen, mirvetuximab soravtansine, troriluzole and tiratricol are among the latest products that the European Medicines Agency has started reviewing for potential EU marketing approval.

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New EU Filings

Elafibranor, Ipsen/Genfit’s investigational oral, once-daily drug for primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

French Regulator At Odds With EMA Over Safety Restrictions For Pseudoephedrine

The product information for all pseudoephedrine-containing medicines in the EU will need to be updated, the European Medicines Agency said.

French Regulator At Odds With EMA Over Safety Restrictions For Pseudoephedrine

The product information for all pseudoephedrine-containing medicines in the EU will need to be updated, the European Medicines Agency said today.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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