Nasdaq7d
Eisai and Biogen Provide Update on Lecanemab Regulatory Review for Alzheimer’s Disease in the European Union
Eisai and Biogen update on lecanemab's EU regulatory review for early Alzheimer’s disease treatment following positive CHMP opinion. Eisai Co., Ltd. and Biogen Inc. have provided an update on ...
MM&M11d
Biogen, Eisai receive FDA nod for monthly Leqembi IV maintenance dosing
Over the weekend, the Food and Drug Administration approved Leqembi, the Alzheimer’s treatment from Eisai and Biogen, for monthly dosing maintenance after patients use it biweekly for 18 months.
Business Insider11d
FDA approves Eisai, Biogen’s sBLA for lecanemab-irmb IV dosing
Eisai (ESAIY) and Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has approved the Supplemental Biologics License Application, sBLA, for once every four weeks lecanemab ...
Bloomberg L.P.7d
EU to Weigh New Safety Data on Biogen, Eisai Alzheimer’s Drug
European Union regulators will review new information relating to the safety of Eisai Co.’s and Biogen Inc.’s medicine for Alzheimer’s disease, providing a response after a meeting next month.
Morningstar11d
Biogen, Eisai Get FDA Nod for Leqembi IV Maintenance Dosing
Biogen and Eisai have won Food and Drug Administration approval of an intravenous maintenance dosing of their Leqembi drug for early Alzheimer's disease. The companies late Sunday said the FDA ...
Nasdaq24d
Eisai and Biogen Announce FDA Acceptance of Lecanemab Subcutaneous Autoinjector Application for Alzheimer's Disease Treatment
Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. FDA has accepted Eisai's Biologics License Application for lecanemab-irmb, marketed as LEQEMBI, which is designed for subcutaneous ...
Morningstar14d
Merck, Eisai See Mixed Keytruda/Lenvima Results in Phase 3 Gastroesophageal Cancer Study
Merck & Co. and Eisai reported mixed results from a late-stage study of the cancer drugs Keytruda and Lenvima in patients with certain types of gastroesophageal cancer. Merck and Eisai on Friday ...
Yahoo Finance24d
FDA To Review Under the Skin Weekly Autoinjector For Biogen/Eisai's Alzheimer's Drug Leqembi
On Monday, the FDA accepted Eisai Co., Ltd. (OTC:ESALY) and Biogen Inc’s (NASDAQ:BIIB) Biologics License Application (BLA) for lecanemab-irmb (Leqembi) subcutaneous autoinjector (SC-AI ...
Seeking Alpha24d
Biogen, Eisai say injectable Alzheimer’s therapy granted FDA review
Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) (OTCPK:ESAIY) announced that the U.S. Food and Drug Administration (FDA) accepted a marketing application for an injectable version of their Alzheimer ...
Investing12d
US FDA OKs monthly maintenance dosing for Eisai/Biogen's Alzheimer's drug
(Reuters) - The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen (NASDAQ:BIIB)'s Alzheimer's drug Leqembi, the companies said on Monday.
Reuters10d
Eisai Co Ltd
The European medicines regulator said on Friday it will review safety information for Eisai and Biogen's Leqembi, nearly three months after it recommended approval for the drug to treat some ...