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New EU Filings

 
• By Neena Brizmohun

Etuvetidigene autotemcel, Fondazione Telethon’s investigational gene therapy for Wiskott-Aldrich syndrome, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.

New EU Filings
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This is a regularly updated searchable list of products that have been filed with the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) under the EU’s centralized authorization procedure. The information is based on the EMA’s monthly updated list of medicines under review at the agency, CHMP monthly meeting agendas, company press releases, and original research by the Pink Sheet.

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EU Biosimilar Filings, Opinions And Approvals

 
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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.

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More from EU CHMP

European Regulator Deals Blow For Lilly’s Alzheimer’s Drug Kisunla

 
• By Francesca Bruce

Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.

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EMA Considers Whether Intrathecal Zolgensma Deserves Fast Tracking

 
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