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Keeping Track: US FDA Approvals Of Mavyret, Idhifa, Vyxeos Headline Week Of Breakthroughs, Hematology And Hematology BTDs

Executive Summary

The latest drug development news and highlights from our FDA Performance Tracker.

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AbbVie's Mavyret Is First 8-Week Pan-Genotypic Combination For HCV

FDA approval of the glecaprevir/pibrentasvir combination could help AbbVie fill a gap resulting from declining sales of Viekira Pak, while challenging Gilead's monopoly in some segments of the market.

Fast-To-Market Play For AstraZeneca's Acalabrutinib With MCL Filing

Never mind MYSTIC, AstraZeneca is pushing the spotlight onto its other oncology assets, and its second-generation BTK inhibitor has just been accepted for filing and given breakthrough status in the US.

Celgene, Agios Ready For Enasidenib Launch After Early Approval

Idhifa is the first treatment for AML patients with IDH2 mutations. The drug will be co-commercialized by Celgene and Agios under their 2010 collaboration and is the latter's first regulatory approval.

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