Drug Approval

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Tesaro puts AstraZeneca; XELJANZ® receives; Innovus nabs; Alexion brings

Tesaro puts AstraZeneca on notice with early FDA nod for Lynparza rival niraparib Tesaro’s closely watched ovarian cancer drug niraparib—now dubbed Zejula—won an FDA nod on 27th March, months before its scheduled decision date. Apart from getting approval, Zejula also got a broader label than its head-to-head rival,...

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US drug approvals plummet in 2016

US drug approvals are on track to drop by more than half in 2016 compared to 2015. The agency had approved 19 new drugs this year as of 9 December, putting it on track for its lowest yearly tally since 2007. The decline is made more dramatic by 2015’s bumper crop of approvals. The FDA approved 45 new drugs last year...

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