The European Medicines Agency has started reviewing 15 new products for potential pan-EU marketing approval, including two hemophilia treatments – fidanacogene elaparvovec, Pfizer/Spark Therapeutics’ gene therapy for hemophilia B, and efanesoctocog alfa, Sobi/Sanofi’s recombinant factor VIII therapy for hemophilia A.
Two Hemophilia Treatments Among 15 New EU Filings
EU marketing authorization applications for a number of new medicines have started the regulatory review process.
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