Eisai and Biogen’s Supplemental Biologics License Application (sBLA) for Leqembi (lecanemab) subcutaneous autoinjector (SC-AI) has been accepted by the US FDA under Priority Review to treat early ...

Previously lecanemab was only approved as an SC injection for maintenance dosing, following an initial 18 month IV phase.

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) administration of ENTYVIO ...

BioArctic AB's (publ) (STO: BIOA B) partner Eisai announced today that the supplemental Biologics License Application (sBLA) ...

New data from two clinical studies demonstrated that Sarclisa administered subcutaneously via an investigational on-body injector shortened treatment time to minutes with similar efficacy and safety ...

This marks the approval of the first and only subcutaneous immune checkpoint inhibitor in Europe that can be administered by a health care provider in as little as one minute RAHWAY, N.J., November 19 ...

ZURICH, Feb. 24, 2025 /PRNewswire/ -- Takeda (TSE: 4502) (NYSE: TAK) announced today that the EMA has approved an additional 2 mL pre-filled pen option for TAKHZYRO® (lanadelumab) for subcutaneous ...

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced ...

If approved, LEQEMBI IQLIK would be the first and only anti-amyloid treatment to offer at-home injection options for ...

OCREVUS subcutaneous (SC) injection offers a new, 10-minute administration of OCREVUS with comparable efficacy and safety to intravenous infusion (IV) OCREVUS SC provides an additional treatment ...