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Drug Approvals

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Latest From Approvals

Zolgensma and Seven Other Products Get CHMP Thumbs Up

Zolgensma should receive a conditional approval, says the European Medicines Agency’s drug evaluation committee, the CHMP.

Europe Approvals

Ide-Cel & Enhertu Sponsors Keep Fingers Crossed For EMA Fast-Track

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.

Drug Review Europe

EU Biosimilar Filings, Opinions and Approvals

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.

European Performance Tracker Approvals

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

Drug Review Europe

Intercept Eyes EU NASH Market

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.

Drug Review Europe

Fennec Banks On EMA’s Seldom-Used PUMA For Sodium Thiosulfate

Fennec Pharmaceuticals says that its new formulation of sodium thiosulfate for preventing cisplatin-induced hearing loss in children targets a critical unmet medical need.

Drug Review Europe
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