AstraZeneca has hit what appears to be a minor speed bump in gaining clearance in the U.S. for its subcutaneous (SC) version ...

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 ...

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.

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) ...

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

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

Subcutaneous administration takes less time and is tied to fewer administration-related reactions than intravenous.

Argenx has filed for FDA approval of subcutaneous efgartigimod, keeping it on track to start selling the sibling of its existing intravenous generalized myasthenia gravis (gMG) treatment Vyvgart. In ...

– 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 ...

Subcutaneous fat is stored just beneath the skin and can be pinched with your fingers. Visceral fat lies deep within the abdominal walls and surrounds the organs. Visceral fat tends to cause bad ...

A subcutaneous version of the newly approved Alzheimer's drug lecanemab (Leqembi) may be on the horizon. Weekly subcutaneous lecanemab 100 mg/mL injection appeared to be as effective at amyloid plaque ...