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Clinical Trials - Page 2

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

Novartis Ianalumab Receives FDA Breakthrough Therapy Designation for Sjögren’s Disease: First Targeted BAFF-R Blocking B-Cell Depleter Demonstrates Statistically Significant Disease Activity Reduction; Regulatory Submissions Planned Q1 2026

NEPTUNUS-1 and NEPTUNUS-2 met primary endpoints with clinically meaningful improvements in ESSDAI and patient-reported outcomes across 779 globally enrolled patients; ianalumab positioned to become first approved targeted treatment for second most prevalent rheumatic autoimmune disease Novartis announced that the U.S. Food and
16 January 2026
Optic Neuritis

FDA Grants Breakthrough Therapy Designation to Oculis’ PRIVOSEGTOR for Optic Neuritis: The First Neuroprotective Treatment in Rare Vision-Threatening Condition

Swiss biotech company, Oculis Holding, achieves significant regulatory milestone following successful Phase 2 ACUITY trial results; global pivotal trials underway for first-in-class therapy addressing critical unmet medical need Oculis Holding AG announced that the Food and Drug Administration (FDA) has granted Breakthrough
12 January 2026
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