FDA Accepts NDA for Novel Parkinson’s Disease TherapyNovember 11th 2022
IPX203 is an oral formulation of carbidopa/levodopa extended-release capsules that, if approved, could provide patients with better symptom control. The FDA assigned a Prescription Drug User Fee Act date of June 30, 2023.
FDA Advisory Committee Votes Against Copiktra in CLL/SLLSeptember 26th 2022
Committee members felt the data on overall survival for patients treated with Copiktra was difficult to interpret, and the therapy was associated with a higher risk of serious side effects and deaths compared with Kesimpta.
FDA Advisory Committee Votes Against Poziotinib for NSCLCSeptember 22nd 2022
Several concerns factored into the decision, including a low overall response rate and high rate of adverse events, a dose that was not optimized and a confirmatory trial that will not likely see results until 2026.