A new study exploring the investigational therapy, Zorpo-cel, met its primary safety and secondary efficacy endpoints in ...
The FDA delays approval AstraZeneca lupus drug Saphnelo for subcutaneous use, pending additional data; intravenous form remains available globally.
Feb 3 (Reuters) - AstraZeneca said on Tuesday that the U.S. health regulator had rejected its application for an ...
Amgen’s bad luck in lupus may finally be coming to an end. Daxdilimab, a monoclonal antibody acquired from Horizon ...
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.
(Yicai) Feb. 5 -- AstraZeneca’s application to bring its new lupus drug anifrolumab, which treats adult Asian patients with the autoimmune disease systemic lupus erythematosus, to the Chinese market ...
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 ...
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 ...
Feb 3 (Reuters) - AstraZeneca said on Tuesday the U.S. health regulator has rejected its application for a self-injectable ...
The FDA has granted Breakthrough Therapy designation for litifilimab for the treatment of cutaneous lupus erythematosus, a chronic autoimmune skin disease.
This transcript has been edited for clarity. For more episodes, download the Medscape app or subscribe to the podcast on Apple Podcasts, Spotify, or your preferred podcast provider. Maureen McMahon, ...