New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add a new product – Tibsovo, Servier’s treatment for IDH1-mutated acute myeloid leukemia and IDH1-mutated cholangiocarcinoma.
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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.
Quviviq is to become the first dual orexin receptor antagonist available on the National Health Service. Just over 20,000 people in England could receive treatment with the drug in its first year, says the health technology assessment institute, NICE.
The European Medicines Agency is to recommend whether the marketing authorization for Currax’s weight management drug should be maintained, varied, suspended or revoked.