EMA Recommends Revoking EU Approval For Novartis’s Sickle Cell Disease Drug
The results of a Phase III study did not confirm the benefits previously seen with Adakveo, the European Medicines Agency said.
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The company has significantly built up its pipeline since divesting its oncology business to Servier, with multiple Phase III readouts for Pyrukynd expected in 2024-2025.
The European Medicines Agency is standing by its recommendation to reject Ipsen’s EU marketing authorization application for Sohonos, for treating fibrodysplasia ossificans progressiva.
Two new products, one for epilepsy and the other for prostate cancer, were recommended for EU approval during the latest monthly meeting of the European Medicines Agency’s human medicines committee, the CHMP.