European 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.
You may also be interested in...
COVID-19 Could Change Attitudes To Flu, Bolster Xofluza
Roche’s first-in-class one-dose antiviral Xofluza has been approved for marketing in the EU to treat influenza in patients aged 12 years or over, and for post-exposure prophylaxis.
Agios’ Phase III Data Move It Closer To First Therapy For Rare Anemia
Strong top-line efficacy in pyruvate kinase deficiency patients who don’t receive regular transfusions looks approvable, analysts say, but Agios will await data in regularly transfused patients.
BioMarin Pulls EU Hemophilia Gene Therapy Filing, But Is Not Giving Up
BioMarin plans to resubmit its marketing application for Roctavian to the European Medicines Agency.