Keeping Track: Novartis' Ribociclib, Tesaro's Niraparib Submitted; Catalyst Clears Path For Firdapse Resubmission

In retrospect, the European Society for Medical Oncology meeting was a showcase for pivotal trial data included in a burst of targeted therapy new drug applications, and more drug development news and highlights from our FDA Performance Tracker.

The past week brought filing news for Novartis AG's ribociclib, Tesaro Inc.'s niraparib, and Ariad Pharmaceuticals Inc.'s brigatinib – all products with significant clinical data presented at the European Society for Medical Oncology (ESMO) 2016 meeting in October. Ribociclib and brigatinib both have breakthrough therapy designations.

While FDA's novel agent approval count has been anemic this year (so far), the pipeline of agents under review for...