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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BeiGene’s Brukinsa Among Nine Drugs To Win EU Marketing Thumbs Up
A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval.
BMS & Pfizer Win Funding ‘Firsts’ In England For Migraine & Heart Disease Drugs
Bristol Myers Squibb and Pfizer both asked the health technology assessment body NICE to evaluate their respective drugs, Camzyos and Vydura, for use in indications that are narrower than those for which they are – or will potentially be – approved.
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.