AstraZeneca wins FDA priority review for Datroway in triple-negative breast cancer, while Saphnelo SC receives a complete ...
The FDA rejected AstraZeneca's subcutaneous Saphnelo application, delaying U.S. approval until 2026, despite positive ...
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics License Application (BLA) for Saphnelo (anifrolumab) for subcutaneous administration in ...
Saphnelo, a human monoclonal antibody, is a type 1 interferon (INF) receptor antagonist that inhibits a key protein in the immune system called the IFNAR receptor. This protein acts like a transmitter ...
Saphnelo (anifrolumab-fnia) is a prescription drug used to treat systemic lupus erythematosus. The drug comes as an intravenous (IV) infusion. It’s usually given once every 4 weeks by a healthcare ...
Positive high-level results from a pre-specified interim analysis of the Phase III TULIP-SC trial in patients with systemic lupus erythematosus (SLE) showed that the subcutaneous (SC) administration ...
People with lupus often need to use medicine to manage their symptoms. Although there are many oral medicines that treat lupus, some people with moderate to severe lupus may not get enough benefit ...
The TULIP-SC trial evaluated the efficacy and safety of the subcutaneous administration of SAPHNELO compared to placebo in participants with moderately to severely active, autoantibody-positive SLE, ...
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