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US FDA Pushes Back GSK’s Momelotinib Decision

Ruling Now Expected By 16 September

 
• By Andrew McConaghie

GSK remains confident of approval despite the delay, with hopes of blockbuster sales for its myelofibrosis candidate.

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• Source: GSK

GSK will have to wait three months longer for the US Food and Drug Administration to make a ruling on its myelofibrosis candidate momelotinib, with the agency pushing back its decision date to 16 September.

The UK-headquartered pharma company announced the delay on 16 June, the same day the regulator had originally pencilled in to...

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