Keeping Track: US FDA Shoots Down Lilly's Baricitinib, Approves Neurocrine's Ingrezza
The latest drug development news and highlights from our FDA Performance Tracker.
You may also be interested in...
Neurocrine Closer To Ingrezza Label Expansion With Huntington’s Chorea Phase III Win
The neuroscience-focused firm plans a 2022 supplemental NDA for Ingrezza following success in the pivotal KINECT-HD study. The biotech needed an R&D success after recent stumbles.
Black Box 'Best Case' Hopes On Vaginal Estradiol Dashed For TherapeuticsMD
Echoing complaints of other recent complete response recipients, TherapeuticsMD charges that US FDA's request for 12-month safety data for the dyspareunia therapy TX004HR is not consistent with earlier communications with agency.
Baricitinib Complete Response May Put Lilly/Incyte Behind IL-6 Blockers In RA
FDA complete response letter seeks additional data on dosing and other safety concerns, delaying potential approval for an NDA that already had been pushed back three months. Interleukin-6 inhibitors sarilumab and sirukumab, now under review at FDA, both could obtain approval before baricitinib.