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Two Hemophilia Treatments Among 15 New EU Filings

Executive Summary

EU marketing authorization applications for a number of new medicines have started the regulatory review process.

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New EU Filings

Beremagene geperpavec, Krystal Biotech’s topical, redosable gene therapy for treating dystrophic epidermolysis bullosa, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

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.

New EU Filings

Imetelstat, Geron’s investigational treatment for transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes, 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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