February 2026 Update on US regulatory review of Saphnelo subcutaneous administration in systemic lupus erythematosus The US Food and Drug Administration (FDA) issued a complete response letter (CRL) ...

Investing.com -- AstraZeneca PLC (ST:AZN) stock fell 1.5% in Tuesday morning trade after the U.S. Food and Drug ...

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 ...

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

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 ...

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 ...

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 ...

Roche is working closely with national health systems in Europe to ensure people with multiple sclerosis can access OCREVUS SC as quickly as possible Basel, 25 June 2024 - Roche (SIX: RO, ROG; OTCQX: ...

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

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 ...