Global Blood Therapeutics Leaves ASH With Momentum Behind Voxelotor In Sickle Cell Disease
Company revealed that US FDA agreed to accelerated approval pathway for voxelotor in sickle cell disease, with focus on stroke prevention. Updated data from a key trial was also released at ASH.
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Keeping Track: Ofev Snags SSc-ILD Indication, Accelerated Approval Reviews For Veverimer And Voxelotor, J&J Gets Its First Vaccine BTD
The latest drug development news and highlights from our US FDA Performance Tracker.
The company's NDA for voxelotor was accepted by the US FDA for priority review with action expected in February, setting up a showdown with Novartis.
Public Company Edition: Moderna's $604m IPO launches as the US stock market is in decline and public biotechs are doing especially poorly. Also, as Shire acquisition closing moves near, Takeda firms up additional financing; and Global Blood, Theravance, Amarin capitalize on good news.