Subcutaneous delivery of hyaluronidase may boost effectiveness of cancer immunotherapy

Monash University researchers, alongside key partner Halozyme Therapeutics, report findings in support of shifting the way ...
Business Wire

Zai Lab Announces Acceptance of Supplemental Biologics License Application with Priority Review for Efgartigimod Alfa Injection (Subcutaneous Injection) in Chronic Inflammatory ...

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration ...
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 ...
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.
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 ...
Healio

FDA approves Opdivo as subcutaneous injection

Please provide your email address to receive an email when new articles are posted on . Opdivo was previously only available intravenously. The approval comes after CHECKMATE-67T study results. Opdivo ...
TMCnet

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

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 ...
Business Wire

Genentech’s Ocrevus Twice-Yearly, 10-Minute Subcutaneous Injection Was Non-Inferior to Intravenous Infusion and Provided Near-Complete Suppression of Brain Lesions

– Late-breaking Phase III results show subcutaneous injection was non-inferior to intravenous infusion based on Ocrevus levels in the blood over 12 weeks – – Ocrevus subcutaneous injection was ...
Healio

FDA approves first twice-a-year, subcutaneous injection for multiple sclerosis

Please provide your email address to receive an email when new articles are posted on . Genentech announced it received FDA approval for Ocrevus Zunovo to treat patients with relapsing and primary ...
Nasdaq

Roche’s subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types

Basel, 14 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ...
FiercePharma

Roche preps for filings after subcutaneous Ocrevus matches up to IV formulation in phase 3 study

Roche’s subcutaneous version of its multiple sclerosis (MS) med Ocrevus triumphed in a key late-stage study, likely setting up a new opportunity for the blockbuster drug. The study, called OCARINA II, ...

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 ...