The FDA rejected AstraZeneca's subcutaneous Saphnelo application, delaying U.S. approval until 2026, despite positive ...

Subcutaneous anifrolumab is superior to placebo in multiple systemic lupus erythematosus disease activity measures at 52 weeks, according to data published in Arthritis & Rheumatology.“As a ...

AstraZeneca has already provided the requested information to the FDA and a decision on the updated BLA is expected in the first half of 2026.

The US Food and Drug Administration rejected a subcutaneous version of AstraZeneca Plc’s lupus medicine that would make it easier to administer.

The FDA delays approval AstraZeneca lupus drug Saphnelo for subcutaneous use, pending additional data; intravenous form remains available 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 ...

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

Investing.com -- AstraZeneca PLC (ST:AZN) stock fell 1.5% in Tuesday morning trade after the U.S. Food and Drug Administration rejected the company’s initial submission for its Saphnelo lupus drug in ...

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

The Surf Bio acquisition comes shortly after Halozyme bought another company with a subcutaneous delivery technology, ...