FDA issues handful of new PDUFA dates

With the government shutdown resolved, FDA has accepted a handful of applications for review during the beginning Feb. 18, according to company announcements.

FDA granted Priority Review to two applications from Genentech Inc. for entrectinib and polatuzumab vedotin.

Entrectinib, an inhibitor of ROS1, TrkA, TrkB, TrkC and ALK, would be the third tissue-agnostic cancer treatment approved by

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