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EU reviewers have recommended marketing approval for two new medicines, but have turned down another product.
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Sponsors of three drugs have withdrawn their EU marketing authorization applications in the middle of the assessment process, including one for a bladder cancer therapy that was recently turned down in the US.
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 European Union, and updates on EU marketing authorization changes recommended by the CHMP.
The European Medicines Agency is meeting this week to consider applications to broaden the use of approved drugs to include new indications in the EU.