Array BioPharma’s Post-Approval Business Strategy Stymied
Following a meeting with the US FDA, Array BioPharma has withdrawn the NDA for its MEK inhibitor binimetinib because of insufficient evidence of clinical benefit in a tough-to-treat subgroup of melanoma patients, that may lead to a rethink of its commercialization strategy.
You may also be interested in...
Keeping Track: US FDA Approves Sickle Cell Therapy Endari; Array Submits Binimetinib Again
The latest drug development news and highlights from our FDA Performance Tracker.
Deal Watch: Array Partners With Ono On Cancer Drugs In Japan, South Korea
French biotechs Servier and ILTOO sign an option agreement for the latter's IL-2 inhibitor for lupus, while Korean biotechs LegoChem and Bridge will team up in idiopathic pulmonary fibrosis.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.