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FDA Roundup: February 13, 2024
… loss, reducing the risk of stroke, heart attack, or heart disease. In addition, the firm offers a product called … However, the products include claims such as treatment of Alzheimer’s disease, lowering blood sugar, or enhancing insulin …
FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval
… ws-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval … Español Today, the … (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a … approval to a traditional approval for the treatment of Alzheimer’s disease. The drug works by reducing amyloid …
FDA Roundup: June 9, 2023
… in patients aged 55 years and older being evaluated for Alzheimer’s disease (AD). Amyloid plaques are abnormal accumulations of …
FDA Roundup: June 6, 2023
… for Leqembi (lecanemab) solution for the treatment of Alzheimer's disease. Leqembi was approved under the accelerated approval pathway for the treatment of Alzheimer’s disease in January, 2023. Confirmatory studies …
FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s Disease
… treat-agitation-symptoms-associated-dementia-due-alzheimers-disease … Español Today, the U.S. Food and Drug … the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment … aspects of care among patients with dementia due to Alzheimer’s disease. ‘Agitation’ can include symptoms ranging …
FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment
… ss-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment … Today, the U.S. Food and Drug … via the Accelerated Approval pathway for the treatment of Alzheimer’s disease. Leqembi is the second of a new category of medications approved for Alzheimer’s disease that target the fundamental …
FDA Grants Accelerated Approval for Alzheimer’s Drug
… approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved … that the drug provides the expected clinical benefit. “Alzheimer’s disease is a devastating illness that can have a …
FDA Approves First Drug to Image Tau Pathology in Patients Being Evaluated for Alzheimer’s Disease
… rug-image-tau-pathology-patients-being-evaluated-alzheimers-disease … Today, the U.S. Food and Drug Administration … drug used to help image a distinctive characteristic of Alzheimer’s disease in the brain called tau pathology. Tauvid … with cognitive impairment who are being evaluated for Alzheimer’s disease. Tauvid is indicated for positron …
FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease
… /fda-approves-new-add-drug-treat-episodes-adults-parkinsons-disease … Español The U.S. Food and Drug Administration today … to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing "off" episodes. An "off" episode is … common neurodegenerative disorder in the U.S. after Alzheimer’s disease. An estimated 50,000 Americans are …
FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer
… marketed as an alternative or additional treatment for Alzheimer’s and other serious diseases. “Substances that …