Healio1d
FDA grants biologics license application for monthly IV Leqembi
The FDA has accepted Eisai and Biogen’s biologics license application for a monthly infusion of IV Leqembi to treat ...
precisionmedicineonline2d
FDA Accepts Eisai's BLA for Subcutaneous Leqembi Maintenance Dosing
The agency expects to issue a decision by Aug. 31, and it is slated to decide on maintenance dosing for an intravenous form of the drug later this month.
Monthly Prescribing Reference2d
Lecanemab SC Formulation Under Review for Early Alzheimer Disease
The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for subcutaneous (SC) maintenance dosing of lecanemab-irmb for the treatment of Alzheimer disease (AD) in ...
GlobalData on MSN2d
Eisai and Biogen’s subcutaneous Leqembi set for FDA review
Eisai and Biogen are one step away from deploying a more convenient version of their jointly developed Alzheimer’s treatment ...
Benzinga.com2d
FDA To Review Under the Skin Weekly Autoinjector For Biogen/Eisai's Alzheimer's Drug Leqembi
The injection process is expected to take, on average, 15 seconds. As part of the SC-AI 360 mg weekly maintenance regimen, ...
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) ...
Merck eyeing 2025 launch for easier-to-use Keytruda
Merck (MRK) stock in focus as the company eyes 2025 launch of subcutaneous Keytruda amid a looming patent cliff for its ...