Amgen’s bad luck in lupus may finally be coming to an end. Daxdilimab, a monoclonal antibody acquired from Horizon ...
The U.S. Food and Drug Administration (FDA) issued a complete response letter requesting additional information from ...
AstraZeneca has hit what appears to be a minor speed bump in gaining clearance in the U.S. for its subcutaneous (SC) version of lupus treatment Saphnelo. | AstraZeneca will have to negotiate what ...
The company is working with the U.S. regulator to move forward with an updated application, adding a decision is expected in the first half of 2026.
AstraZeneca said on Tuesday that the U.S. health regulator had rejected its application for an easier-to-use version of lupus ...
The FDA has granted Breakthrough Therapy designation for litifilimab for the treatment of cutaneous lupus erythematosus, a chronic autoimmune skin disease.
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