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News about "systemic lupus erythematosus"
Merck Wins US FDA Breakthrough Therapy Designation Status for Enpatoran in Lupus
Merck has received US Food and Drug Administration (FDA) Breakthrough Therapy Designation (BTD) for enpatoran in lupus patients with active skin manifestations, advancing a potential first approved treatment for cutaneous lupus.
Systemic Lupus Erythematosus | 09/07/2026 | By News Bureau
Johnson & Johnson's Nipocalimab Shows Sustained Disease Reduction in Lupus Phase 2 Study
The monoclonal antibody met its primary endpoint in the JASMINE trial and demonstrated continued improvements in disease activity through 52 weeks in adults with moderate-to-severe systemic lupus erythematosus.
Systemic Lupus Erythematosus | 04/06/2026 | By News Bureau
AstraZeneca Wins US Approval for Self-Administered Saphnelo Pen for Lupus Treatment
AstraZeneca launches a self-injectable version of Saphnelo, offering lupus patients a more convenient treatment option with proven efficacy and safety.
Systemic Lupus Erythematosus | 28/04/2026 | By News Bureau | 170
Roche Secures FDA Review for Lupus Drug Gazyva
Roche’s Gazyva moves closer to approval for systemic lupus erythematosus after FDA accepts application backed by Phase III trial results showing improved disease control and remission rates.
Systemic Lupus Erythematosus | 22/04/2026 | By News Bureau | 102
Roche's Gazyva/Gazyvaro Shows Positive Results for Systemic Lupus Erythematosus in Phase III trials
The ALLEGORY study met its primary endpoint showing a higher percentage of people achieved a minimum four-point improvement in SLE Responder Index 4 (SRI-4) at one year (52 weeks) with Gazyva/Gazyvaro versus standard therapy.
Systemic Lupus Erythematosus | 05/11/2025 | By Dineshwori | 342
China's Leads Biolabs Wins FDA Nod to Begin First-in-Human Trial of Novel Autoimmune Therapy
The US Food and Drug Administration (FDA) has approved Leads Biolabs’ first-in-human Investigational New Drug (IND) application for LBL-047, a novel therapeutic candidate for the treatment of autoimmune diseases such as systemic lupus erythematosus, dermatomyositis, IgA nephropathy and Sjögren's syndrome.
Systemic Lupus Erythematosus | 22/09/2025 | By Dineshwori | 404
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