Crunch Time At EMA For Luspatercept And Glasdegib
Eight new marketing applications including ones from BMS/Acceleron Pharma and Pfizer are up for an opinion at the April meeting of the European Medicines Agency’s drug evaluation committee, the CHMP.
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Setmelanotide, which is being developed to treat insatiable hunger and early-onset severe obesity in people with rare genetic disorders, was also recently submitted to the US regulator for approval.
Novartis is hoping to address EU regulators’ concerns regarding Piqray and to persuade them that the new advanced breast cancer treatment is fit for approval.
Keeping Track: Oncology Submissions From Blueprint, Y-mAbs, BMS/bluebird; Approvals For BMS’ Reblozyl, LFB’s SevenFact
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.