FDA Uses Real-World Data to Approve Boostrix for Prevention of Infection in InfantsOctober 8th 2022
Regulators used a re-analysis of data from an observational case-control study of Tdap vaccine effectiveness to show that Boostrix given in the third-trimester prevented pertussis among infants.
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.
FDA Approves Lower Dose Gadolinium-Based Contrast AgentSeptember 21st 2022
Elucirem requires half the gadolinium dose of existing gadolinium-based contrast agents, addressing practitioners’ concerns about gadolinium exposure during MRIs. It will be available in bottle and pre-filled syringe form.
FDA Reschedules Advisory Committee Meeting for COVID-19 TreatmentSeptember 20th 2022
Veru is seeking an emergency use authorization for sabizabulin, a first-in-class treatment for hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome. The advisory committee meeting is now Nov. 9, 2022.