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 EU, and updates on EU marketing authorization changes recommended by the CHMP.
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GSK’s Arexvy vaccine for preventing lower respiratory tract disease caused by respiratory syncytial virus in adults aged 60 years and older is among the latest products that the European Medicines Agency said should be approved for use in the EU.
A number of new drugs have taken a major step towards being approved for use in the EU after receiving the nod from the European Medicines Agency’s human medicines committee, the CHMP. Meanwhile, the marketing applications for three drugs have been withdrawn.
Janssen’s Akeega is among the latest drugs that the European Medicines Agency says should be approved for use in the EU. Meanwhile, MSD/Ridgeback Biotherapeutics plan to appeal the agency’s rejection of their COVID-19 treatment.