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

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 FDA is reviewing an application seeking expanded approval of an under-the-skin injection version of Leqembi (lecanemab).

The collaboration between ten23 health and BD aims to commercialize the BD Libertas wearable injector for large-volume ...

Subcutaneous anifrolumab is superior to placebo in multiple systemic lupus erythematosus disease activity measures at 52 ...

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 ...

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 ...

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

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

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 ...

On Feb. 14, the agency approved the drug, a biosimilar to Novolog, for glycemic control improvement in adult and pediatric diabetic patients. The subcutaneous medication is approved in a 3 milliliter, ...