FDA Priority Review granted for GSK’s Zejula
The US Food and Drug Administration (FDA) has accepted Glaxo Smith Kline’s application for Zejula (niraparib) in late stage ovarian cancer with priority review.
The company announced that Tesaro, an oncology-focused business acquired by GSK, submitted a supplemental New Drug Application (sNDA) to the governing body, with an expected action date of 24 October 2019.
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