News about "Breakthrough Therapy"

FDA Grants Breakthrough Therapy Designation to Biogen's Litifilimab for Cutaneous Lupus

FDA Grants Breakthrough Therapy Designation to Biogen's Litifilimab for Cutaneous Lupus

Biogen’s investigational monoclonal antibody litifilimab receives FDA Breakthrough Therapy designation, marking a major step toward targeted treatment for cutaneous lupus erythematosus.

Breakthrough Therapy | 29/01/2026 | By News Bureau 158

Novartis' Ianalumab Receives FDA Breakthrough Therapy Designation for Sjogren's Disease

Novartis' Ianalumab Receives FDA Breakthrough Therapy Designation for Sjogren's Disease

The FDA has granted Breakthrough Therapy designation to Novartis’ ianalumab for Sjögren’s disease, accelerating its review as a potential first targeted treatment, with global filings planned from 2026.

Breakthrough Therapy | 19/01/2026 | By News Bureau 180


 

 

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