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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FibroGen’s Roxadustat Faces US FDA Scrutiny On ‘Prominent’ Safety Signals Relative To Erythropoietin
Risks of serious thrombotic events, seizures and infection make the benefits of the first-in-class oral drug for treating anemia related to chronic kidney disease ‘difficult to calculate’ despite demonstrated improvements in hemoglobin, FDA says in advisory committee briefing document.
EMA OKs BMS/bluebird bio’s CAR-T Abecma For Multiple Myeloma
A gene therapy for multiple myeloma, a new drug for achondroplasia, and the first biosimilar version of Roche’s Lucentis are among eight products recommended for EU marketing authorization this week.
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.