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.
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Keeping Track: Biosimilar Submissions Galore (And An Approval), Bayer Gets An Oncology Approval, KemPharm Resubmits Apadaz NDA
The latest regulatory submission news and highlights from our US FDA Performance Tracker.
The latest drug development news and highlights from our FDA Performance Tracker.
FDA has three NDAs set for public advisory committee review at the end of March and early April, the first 'real' committee meetings in five months. Oops. Make that two.