MPR

Subcutaneous Lecanemab Starting Dose Under Review for Alzheimer Disease

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

Eisai and Biogen’s subcutaneous Leqembi given FDA Priority Review for early Alzheimer’s

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 ...

Leqembi® Iqlik™ (lecanemab-irmb) supplemental Biologics License Application regarding subcutaneous starting dose granted Priority Review by the US FDA

BioArctic AB's (publ) (STO: BIOA B) partner Eisai announced today that the supplemental Biologics License Application (sBLA) for Leqembi Iqlik subcutaneous autoinjector (SC-AI) as a weekly starting ...
Drug Store News

Sandoz offers generic Remodulin for subcutaneous administration

Sandoz is offering treprostinil injection for subcutaneous administration to treat patients diagnosed with pulmonary arterial hypertension. Sandoz treprostinil injection was the first generic of ...

FDA Accepts LEQEMBI® IQLIKTM (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease under ...

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

Roche’s OCREVUS subcutaneous administration approved by European Commission, as first and only twice-a-year injection for relapsing and primary progressive multiple sclerosis

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 ...
Cure Today

Delving into Subcutaneous Versus Intravenous Opdivo in Solid Tumors

Dr. Balazs Halmos discusses the significance of the FDA approval of the subcutaneous injection formulation of Opdivo for patients with solid tumors. The Food and Drug Administration (FDA) approval of ...
Nasdaq

FDA Approves Merck’s KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Injection for Subcutaneous Use in Adults Across Most Solid Tumor Indications for ...

KEYTRUDA QLEX is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute RAHWAY, N.J.--(BUSINESS WIRE)-- Merck ...
FierceBiotech

Subcutaneous Administration of Single-Agent VELCADE Demonstrates Efficacy Consistent with Intravenous Administration

ORLANDO, Fla.--(BUSINESS WIRE)-- Millennium: The Takeda Oncology Company today reported results from a randomized, international Phase III clinical trial comparing subcutaneous and intravenous ...
FiercePharma

U.S. Food and Drug Administration Approves Subcutaneous Formulation of ORENCIA® (abatacept), a Proven Non-Anti-TNF B

First biologic available in both subcutaneous (SC) and intravenous (IV) formulations for the treatment of rheumatoid arthritis Subcutaneous ORENCIA demonstrated similar efficacy (non-inferior for ...
Taiwan News

FDA Accepts LEQEMBI® IQLIK™ (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer’s Disease ...

LEQEMBI is currently approved in 53 countries and regions and is under regulatory review in 7 countries. In August 2025, the US FDA approved LEQEMBI IQLIK 360 mg for weekly subcutaneous maintenance ...