News about "Breakthrough Therapy"

US FDA Grants Breakthrough Therapy Designation to Lilly's Olomorasib for Advanced Pancreatic Cancer

US FDA Grants Breakthrough Therapy Designation to Lilly's Olomorasib for Advanced Pancreatic Cancer

The US FDA has granted Breakthrough Therapy designation to Eli Lilly's investigational KRAS G12C inhibitor, olomorasib, for treating previously treated advanced pancreatic cancer, reinforcing its potential across difficult-to-treat KRAS-driven cancers.

Breakthrough Therapy | 04/08/2026 | By News Bureau

US Food and Drug Administration Clears Expanded Access Pathway for Daraxonrasib

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 396

Axsome Therapeutics Secures US Food and Drug Administration Approval for Auvelity in Alzheimer's Agitation

Axsome Therapeutics Secures US Food and Drug Administration Approval for Auvelity in Alzheimer's Agitation

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 106

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 203

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 286


 

 

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