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FDA Roundup: May 7, 2024
… Lilly and Company, for the treatment of early symptomatic Alzheimer’s disease. FDA and invited participants may attend the meeting …
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 Approves Many New Drugs in 2023 that Will Benefit Patients and Consumers
… over-the-counter. Our 2023 actions target a wide range of disease areas. For example, we approved treatments for … conditions, such as amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and migraine. Moreover, we took approval actions for …
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 …
Remarks by Commissioner Robert Califf to the 2023 Food and Drug Law Institute (FDLI) Annual Conference - 05/17/2023
… approved treatments. We are committed to supporting rare disease research, engaging patients and caregivers, and … review processes to help advance medical products for rare disease patients. In 2022, we approved the 40th biosimilar, … could see significant reductions in rate of progression in Alzheimer’s disease. In addition, whole new classes of drugs …
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 …
Many Important Drugs Approved in 2021 as COVID-19 Pandemic Continues
… including treatments for diabetes, chronic kidney disease, and chronic weight management. Autoimmune, … inflammatory and lung diseases, such as inflammatory bowel disease and cystic fibrosis. Neurological conditions, such as Alzheimer’s disease, opioid overdose, and migraine. …
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 …
2020: A Strong Year for New Drug Therapy Approvals – Despite Many COVID-19 Challenges
… These new approvals include: Advances to treat infectious disease, including the first FDA-approved medication in the … such as those to treat certain patients with Parkinson’s disease, migraine, and multiple sclerosis; Heart, blood, … to help clinicians assess patients being evaluated for Alzheimer's disease, a new diagnostic for finding tumors …
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 …
Remarks by Dr. Sharpless to the 2019 Biopharma Congress - 10/07/2019
… an ever-improving state of biomedical knowledge about a disease to clarify and streamline our process of review for … going on) in certain neuro-degenerative diseases such as Alzheimer’s Disease, Parkinson’s Disease, and Amyotrophic … and development is very hard. I see similar issues for Alzheimer’s and Parkinson’s. I see different but related …
Remarks by Dr. Sharpless to the Research!America 2019 National Health Research Forum - 09/05/2019
… research and producing the science that we need to prevent disease and diagnose and treat our patients. That effort is … in the last two decades that has been breath-taking Take a disease like malignant melanoma. When I was a fellow at the … in 1995, this was the worst cancer imaginable. Metastatic disease was terrible, nothing worked, and most patients were …
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 …
How FDA Plans to Help Consumers Capitalize on Advances in Science
… understanding of the genetic and protein bases of human disease. These developments are already being translated into … to develop such natural history models in Parkinson’s disease, Huntington’s disease, Alzheimer’s disease, and muscular dystrophy. An important …
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 …