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 ...

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 ...

FDA’s three-month extension was triggered by a major amendment after the agency requested additional information during priority review, necessitating more time to evaluate newly submitted materials.

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.

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 ...

Amjevita (adalimumab-atto) is a brand-name drug prescribed for several inflammatory conditions in adults and some children. Amjevita comes as a solution for subcutaneous injection. The dosage can vary ...

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, ...

PD-1 inhibitors belong to a class of medications known as immune checkpoint inhibitors, which have become an important part of many modern cancer treatment plans. PD-1 inhibitors work by helping the ...

Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period ...