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UK Multiple Myeloma Patients Allowed Early Access To Sanofi’s Isatuximab

Executive Summary

The UK scheme allows patients with early access to promising new unlicensed medicines when there is a clear unmet medical need.

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Sanofi appears to have failed to convince the European Medicines Agency that its just-filed marketing authorization application for isatuximab should be granted accelerated assessment. AB Science's request regarding its planned MAA for masitinib has been rejected and Alnylam is declining to disclose the fate of its request relating to givosiran. See our latest updates in the tracker below.

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