New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, including Quviviq (daridorexant), Idorsia's treatment for adult patients with insomnia.
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The European Medicines Agency has delivered its verdict on the latest medicines it believes should be approved for marketing in the EU. By contrast, it has given the thumbs down to one biosimilar anticancer drug and its duplicate.
Oncopeptides is nearing the end of the regulatory review cycle in the EU for its multiple myeloma drug, melphalan flufenamide. The product has had an erratic journey in the US, where it was approved but then withdrawn, and the withdrawal was subsequently rescinded.
The European Medicines Agency’s human medicines committee, the CHMP, is expected to decide whether 11 drugs should be recommended for marketing approval during its latest monthly meeting, which started today.