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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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.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include six new products, including bluebird bio's Skysona, the first gene therapy approved in the EU to treat early cerebral adrenoleukodystrophy.