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January 19, 2026

FDA grants Novartis’ ianalumab breakthrough therapy status for Sjögren’s disease

Novartis has announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to ianalumab, a treatment for Sjögren’s disease, the second most prevalent rheumatic autoimmune condition.

The latest FDA recognition is supported by positive results from several studies, including two replicate Phase III trials. Credit: Motortion Films / Shutterstock.com.