EU CHMP Opinions and MAA Updates
Executive Summary
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...
BioMarin’s Hemophilia Gene Therapy Among Nine Products On Track For EU-Wide Approval
Four orphan drugs and a new COVID-19 vaccine are among the latest products that the European Medicines Agency says should be approved.
EMA Gives Oncopeptides’ Multiple Myeloma Drug The Thumbs Up; Keeps US FDA In Loop
With Pepaxti now on track for pan-EU marketing approval to treat patients with triple class refractory multiple myeloma, Oncopeptides is in talks with the Food and Drug Administration to achieve a clear path forward for the drug in the US where it has experienced difficulties despite being granted an accelerated approval.
Valneva Wins EU Nod For COVID-19 Vaccine
In contrast with the five COVID-19 vaccines that are approved in the EU under conditional marketing authorizations, the European Medicines Agency has recommended that Valneva’s vaccine receive a standard approval.