Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Array Withdraws Binimetinib's US Filing On Heels Of Late-Cycle Meeting With FDA
Company explored ‘a number of paths to approval’ with agency, but modest progression-free survival benefit in monotherapy treatment of NRAS-mutant melanoma appears to have doomed the new drug application, which was pulled less than two weeks before advisory committee review.
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Following a meeting with the US FDA, Array BioPharma has withdrawn the NDA for its MEK inhibitor binimetinib because of insufficient evidence of clinical benefit in a tough-to-treat subgroup of melanoma patients, that may lead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.
OTC Hangover Remedy Safety On Tap For FDA Advisory Committees
CDER schedules an NDAC and DSRMAC joint meeting while also negotiating with industry stakeholders on a potential proposal for a user fee program to support FDA’s work on finalizing monographs or amending monographs with additional ingredients or indications.