lupus

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

Fierce Biotech

FDA to ‘carefully shepherd’ CAR-T for autoimmune disease: Prasad

Feb 3, 2026 11:40am

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 Gazyva tees up another lupus expansion with phase 3 win

Nov 3, 2025 11:41am

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

Sep 17, 2025 11:47am