USFDA nod to Leqembi IV maintenance dosing for treatment of early Alzheimer's Disease: Eisai, Biogen Ruchika Sharma27 Jan 2025 12:22 PM ISTTokyo: Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental...
USFDA approvals bounce back in 2023, sparking hopes of biotech recovery Ruchika Sharma3 Jan 2024 3:22 PM ISTThe U.S. Food and Drug Administration approved nearly 50% more novel drugs in 2023 than in 2022, putting it back on pace with historical levels, an...
Biogen, Eisai get Japanese nod for Leqembi Intravenous Infusion for Alzheimer's Disease Ruchika Sharma25 Sept 2023 12:30 PM ISTTokyo: Eisai Co., Ltd. and Biogen Inc. have announced that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody LEQEMBI...
FDA approves first treatment for Alzheimer's disease Dr. Kamal Kant Kohli8 July 2023 11:00 AM ISTThe US Food and Drug Administration has granted full approval to Lecanemab (Leqembi) as first Alzheimer's treatment targeted at the disease...
USFDA grants traditional approval for Eisai Leqembi for Alzheimer's disease treatment Ruchika Sharma7 July 2023 1:30 PM ISTStockholm:BioArctic AB's (publ)partner Eisai has announced that the U.S. Food and Drug Administration, FDA, has approved the supplemental Biologics...
FDA clears LEQEMBI injection for Treatment of Alzheimer's Disease Dr. Kamal Kant Kohli13 Jun 2023 10:45 AM ISTThe U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) has voted unanimously that the...
Eisai seeks marketing nod for Lecanemab for early Alzheimer's disease treatment in South Korea Ruchika Sharma11 Jun 2023 12:45 PM ISTLecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of...
USFDA advisory committee votes unanimously to confirm clinical benefit of Leqembi for Alzheimer's Disease Ruchika Sharma10 Jun 2023 1:30 PM ISTTokyo: Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System...
USFDA advisers to weigh full nod for Eisai-Biogen Alzheimer's drug Leqembi Ruchika Sharma11 April 2023 10:00 AM ISTLeqembi belongs to a class of treatments that aim to slow the advance of the neurodegenerative disease by removing sticky clumps of the toxic protein...
USFDA grants priority review for Eisai Alzheimer's drug LEQEMBI Ruchika Sharma8 March 2023 10:00 AM ISTTokyo: Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s supplemental Biologics...
FDA approves Leqembi for treatment of Alzheimer's disease Dr. Kamal Kant Kohli9 Jan 2023 8:00 PM ISTUSA: The US Food and drug administration has granted approval to a new drug (Leqembi) designed to slow cognitive decline in patients with early...
