Saphnelo

Pharma

FDA rejection letters flag data concerns for AZ, GSK biologics

The FDA cited “critical data quality issues” in rejecting AZ's Saphnelo for SLE, and it ruled that GSK's Exdensur lacked “adequate evidence” in CRSwNP.

Angus Liu Mar 3, 2026 11:30am

FDA rejects AZ's subcutaneous version of lupus drug Saphnelo

Feb 3, 2026 9:55am

AZ touts phase 3 lupus win for subcutaneous Saphnelo

Jan 6, 2026 11:44am

Roche's cancer med Gazyva scores FDA nod in lupus nephritis

Oct 20, 2025 10:15am

AZ's Fasenra flunks COPD trial as Saphnelo makes grade in lupus

Sep 17, 2025 11:47am

High magnification micrograph of diffuse proliferative lupus nephritis

Off-label drugs fall out of favor in lupus

Jun 16, 2023 10:16am