On July 2, 2024, the US Food and Drug Administration (FDA) approved Kisunla (donanemab-azbt) injection for treating Alzheimer’s disease, marking a significant advancement in the fight against this debilitating condition. Teresa Buracchio, Director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, highlighted the drug’s efficacy in reducing cognitive and functional decline in patients with mild cognitive impairment and mild dementia stages of Alzheimer’s disease.
This approval underscores the FDA’s commitment to facilitating the availability of safe and effective treatments for Alzheimer’s disease. Additionally, the FDA announced the revocation of the regulation authorizing the use of brominated vegetable oil (BVO) in food, effective August 2, 2024, due to potential adverse health effects identified in collaboration with the National Institutes of Health (NIH).
The FDA also reported the expansion of the Total Product Life Cycle Advisory Program by the Center for Devices and Radiological Health (CDRH) to accelerate the development of innovative medical devices. The FDA updated its advisory on the investigation of illnesses related to Diamond Shruumz-brand products, including a recall initiated by Prophet Premium Blends, LLC. These updates reflect the FDA’s ongoing efforts to ensure public health and safety through rigorous scientific evaluation and regulatory oversight.
