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Friday, January 16, 2026

Novartis (NVS) Gains FDA Breakthrough Status for Sjogren's Disease Drug

 Novartis (NVS) has achieved a significant milestone as the U.S. Food and Drug Administration granted Breakthrough Therapy designation to ianalumab, a treatment aimed at Sjogren's disease, a common rheumatic autoimmune condition. This designation could expedite the development and review process. Novartis anticipates submitting ianalumab for global regulatory approval starting in 2026. Upon approval, ianalumab would become the first specifically targeted therapy for Sjogren's disease, addressing a critical need for effective treatments currently lacking for this debilitating disease.

https://www.gurufocus.com/news/4115715/novartis-nvs-gains-fda-breakthrough-status-for-sjogrens-disease-drug

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