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Update on FDA complete response letter to AZ regarding BLA hold for anifrolumab (Saphnelo) for SC use in SLE. CRL originally issued 10/10/25, but announced 2/3/26. FDA CRL cites critical data quality w/ key analyses in SC-TULIP study. A BLA decision expected in 1st half of 2026 https://t.co/zuwtsdL6I9
Dr. John Cush
Mar-10-2026
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