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Latest From Approvals
Zolgensma should receive a conditional approval, says the European Medicines Agency’s drug evaluation committee, the CHMP.
Companies are due to learn this week whether the European Medicines Agency will fast-track its review of their soon-to-be-filed EU marketing applications.
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.
New medicines under evaluation at the European Medicines Agency.
Analysts believe that pan-EU authorization for Intercept Pharmaceuticals’ obeticholic acid for advanced fibrosis due to nonalcoholic steatohepatitis may come in the first quarter of 2021.
Fennec Pharmaceuticals says that its new formulation of sodium thiosulfate for preventing cisplatin-induced hearing loss in children targets a critical unmet medical need.
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