Sanofi Genzyme’s Treatment For Pompe Disease On Track For EU Approval
EMA Rejects Kyowa’s Parkinson’s Disease Drug
EU reviewers have recommended marketing approval for two new medicines, but have turned down another product.
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BeiGene’s Brukinsa Among Nine Drugs To Win EU Marketing Thumbs Up
A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval.
One In, One Out: Mirum Seeks New EU Indication For Maralixibat, Withdraws Another
Sponsors of three drugs have withdrawn their EU marketing authorization applications in the middle of the assessment process, including one for a bladder cancer therapy that was recently turned down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.
EU CHMP Opinions and MAA Updates
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.