Keeping Track: Xiidra, New Repatha Regimen Approved; Abuse-Deterrent Opioid Gets Negative, But Timely, Response
The latest drug development news and highlights from our FDA Performance Tracker.
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Merck's Keytruda may not be only oncologic with indication for cancer patients defined by molecular signature, not tissue of origin, for long: Ignyta's entrectinib and Loxo Oncology's larotrectinib are positioned for breakthrough-designated tissue-agnostic NDA submissions in NTRK fusion-positive cancers in 2018.
Keeping Track: Approval Elusive For Biosimilar Neulasta; Valeant Gets A Nod And A No From FDA; Submissions From Amgen, Puma, Bristol
The latest drug development news and highlights from our FDA Performance Tracker
By examining the "totality of the data" including a Phase II study, FDA approved drug for both measures of dry eye, despite mixed results in pivotal trials.