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News about "Breakthrough Therapy"
US Food and Drug Administration Clears Expanded Access Pathway for Daraxonrasib
Regulator issues “safe to proceed” letter to Revolution Medicines, enabling early patient access to investigational therapy for advanced pancreatic cancer.
Breakthrough Therapy | 04/05/2026 | By News Bureau | 242
First-in-class therapy approved to treat agitation linked to Alzheimer’s disease, addressing a major unmet need for patients and caregivers.
Breakthrough Therapy | 04/05/2026 | By News Bureau
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 | 188
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 | 246
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