Keeping Track: Immuno-Oncologics And Abuse-Deterrent Opioids Take Center Stage (Again); Jardiance CV Claim Approved
The latest drug development news and highlights from our FDA Performance Tracker.
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Keeping Track: Cardio, Antibiotic Approvals Put FDA Over Last Year's Novel Drug Count
The latest drug development news and US FDA highlights from our Performance Tracker.
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: US FDA Clears Three Novel Agents Over Three Days – Bavencio, Symproic And Xadago
The latest drug development news and highlights from our US FDA Performance Tracker.