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.
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Four orphan drugs and a new COVID-19 vaccine are among the latest products that the European Medicines Agency says should be approved.
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.
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.