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Lilly's donanemab was declined accelerated approval by the FDA in January 2023, and on March 8, the agency said it would hold a meeting of its advisers to discuss the drug, further delaying its ...
The approval for donanemab, to be sold under the brand name Kisunla, followed the recommendations of the agency's outside experts, who unanimously backed its use in patients with early Alzheimer's ...
Lilly told a committee of FDA advisers in June that late-stage clinical research data showed “highly meaningful results” for people who took donanemab, with about 35% lower risk of progression ...
Donanemab, sold under the brand name Kisunla, is a monoclonal antibody used for the treatment of Alzheimer's disease. [1] [2] Donanemab was developed by Eli Lilly and Company. [3] [4] The most common side effects include amyloid-related imaging abnormalities and headache. [2] Donanemab was approved for medical use in the United States in July 2024.
A panel of brain and Alzheimer’s experts convened by the U.S. Food and Drug Administration (FDA) voted unanimously on June 10 that a new Alzheimer’s drug developed by Eli Lilly, called ...
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form. [11]
Romosozumab, sold under the brand name Evenity (/ ɪ ˈ v ɛ n ɪ t i / ih-VENN-ih-tee or with the pin-pen merger, / ɪ ˈ v ɪ n ɪ t i / ih-VINN-ih-tee), is a medication used to treat osteoporosis. [ 7 ] [ 8 ] It has been found to decrease the risk of fractures of the spine .
The FDA approved a new Alzheimer’s drug that has been shown in ... The drug donanemab, which will be sold under the brand name Kisunla, is a monoclonal antibody infusion given every four weeks ...