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Europe Approvals Drug Review

EMA Recommends Revoking EU Approval For Novartis’s Sickle Cell Disease Drug

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Executive Summary

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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EMA Backs EU Approval For Ztalmy & Pylclari; Roches Withdraws EU Filing For AMD Implant

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.

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 EU, and updates on EU marketing authorization changes recommended by the CHMP.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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