Latest From AB Science
Will Chugai's European marketing authorization application for satralizumab be fast-tracked when the company files for approval? The European Medicines Agency's drug evaluation committee, the CHMP, will decide this week.
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.
After two years on clinical hold, the French biotech has resolved quality and pharmacovigilance problems that forced it to suspend studies of masitinib, moving it a step closer to restarting trials in its home country.
Accelerated assessment requests at the European Medicines Agency.
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