EU Approval Decision Delay For BMS’s Ozanimod
Company Needed More Time To Answer Questions On New MS Product
BMS should find out mid-2020 whether its new MS drug will be approved in the EU.
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Zolgensma should receive a conditional approval, says the European Medicines Agency’s drug evaluation committee, the CHMP.
Zeposia, one of three Celgene candidates central to last year’s merger with BMS, obtains US FDA approval in relapsing MS. BMS, however, will delay the launch due to the COVID-19 pandemic.
A dozen applications for new drugs and significant new indications are on the US FDA’s calendar of goal dates, including breakthrough-designated applications from Bristol-Myers Squibb and Boehringer Ingelheim.