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EU Accelerated Assessment Tracker

 
• By Vibha Sharma

Janssen’s two investigational Ebola vaccines are among four new products recently granted fast-track review by the European Medicines Agency. GlaxoSmithKline and Viiv Healthcare are not disclosing the outcomes of accelerated assessment requests they have made.

The tracker below provides information on accelerated assessment requests for planned marketing authorization applications (MAAs) that are known to have come before the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for a decision since January 2018.

This latest edition has been updated to reflect the fact that four planned MAAs were granted accelerated assessment at the CHMP’s September meeting, while one was rejected. Accelerated assessment was...

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EU CHMP Opinions And MAA Updates

 
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

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Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A

 
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