A major amendment has prompted the FDA to extend its review of subcutaneous lecanemab as a starting dose for early Alzheimer disease.
Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the supplemental Biologics License ...
BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the supplemental ...
The US Food and Drug Administration (FDA) has approved the biologics license application for a subcutaneous formulation of lecanemab (Leqembi Iqlik) for weekly maintenance dosing to treat Alzheimer’s ...
Subcutaneous Sarclisa, administered via OBDS, showed non-inferior efficacy to IV Sarclisa in relapsed/refractory multiple myeloma patients. The IRAKLIA study enrolled 532 patients globally, ...
Leqembi (lecanemab-irmb) is a prescription drug that’s used to treat Alzheimer’s disease. The drug comes as a liquid that’s given as an infusion into a vein. It is usually given once every 2 weeks.
TOKYO and CAMBRIDGE, Mass., Jan. 25, 2026 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate ...
A person receives subcutaneous immunotherapy as an injection under the skin. This treatment method has shown similar effectiveness to intravenous (IV) infusions that healthcare professionals often use ...
The FDA has approved Saphnelo (anifrolumab-fnia) for subcutaneous administration in patients with systemic lupus ...
Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) ...