Back to School: How biopharma can reboot drug development. Access exclusive analysis here

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

Read the full 557 word article

Trial Subscription

Get a two-week free trial subscription to BioCentury

SIGN UP

Article Purchase

This article may not be distributed to non-subscribers
More Info >PURCHASE