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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Oncology: Tissue-Agnostic Indications Advance Under US FDA's Breakthrough Umbrella
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
Shire's Xiidra Gets Advantageous Label Covering Signs, Symptoms Of Dry Eye Disease
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.