News about "Sanofi"

US FDA Approves Sanofi's Tzield to Delay Type 1 Diabetes Progression in Children

Sanofi’s Tzield gains US FDA approval to delay stage-III Type 1 Diabetes in children aged one year and above, the first disease-modifying therapy for stage-II T1D.

Sanofi | 24/04/2026 | By News Bureau

US Food and Drug Administration Extends Review Timeline for Sarclisa Subcutaneous Formulation

FDA extends review timeline for Sanofi’s Sarclisa subcutaneous formulation, a potential first-in-class on-body injector therapy for multiple myeloma patients.

Sanofi | 23/04/2026 | By News Bureau

European Commission Approves Dupixent for Young Children with Chronic Spontaneous Urticaria

The European Commission has expanded approval of Dupixent to children aged 2–11 with chronic spontaneous urticaria, offering a targeted treatment for those unresponsive to standard antihistamines.

Sanofi | 15/04/2026 | By News Bureau

Sanofi's Lunsekimig Shows Promising Phase II Results in Asthma and Nasal Polyps Studies

The novel dual-targeting Nanobody met primary and key secondary endpoints in asthma and chronic rhinosinusitis trials, demonstrating improved outcomes and a favourable safety profile.

Sanofi | 08/04/2026 | By News Bureau

EU Grants Conditional Approval to Rezurock for Chronic GVHD Treatment

European Commission authorises belumosudil for patients aged 12 plus with limited treatment options, marking a significant advance in managing a life-threatening post-transplant condition.

Sanofi | 01/04/2026 | By News Bureau

Dupixent Approval in Japan Boosts Biologics Manufacturing Demand for Sanofi and Regeneron

The Ministry of Health, Labour and Welfare has granted marketing and manufacturing authorization to Dupixent (dupilumab) for the treatment of adults with moderate-to-severe bullous pemphigoid (BP), a rare and debilitating skin disorder.

Sanofi | 25/03/2026 | By Darshana |  120

Sanofi Secures FDA Breakthrough Designation for Rare Disease Therapy

Sanofi has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its investigational drug venglustat, aimed at treating neurological symptoms associated with type 3 Gaucher disease (GD3).

Sanofi | 19/03/2026 | By Darshana |  120

Sanofi Board Nominates Christel Heydemann as Independent Director

Sanofi has nominated Christel Heydemann as an Independent Director, subject to shareholder approval at its AGM on 29 April. The company also announced that Patrick Kron, Independent Director and Chairman of the Nomination, Governance and CSR Committee, will step down at the end of his term.

Sanofi | 07/03/2026 | By News Bureau |  154

Japan Grants Orphan Drug Designation to Sanofi's Rilzabrutinib

Sanofi’s rilzabrutinib has received Orphan Drug Designation in Japan for IgG4-related disease (IgG4-RD), supported by positive phase-II study results. The decision marks the therapy’s third global orphan designation in this indication, underscoring Sanofi’s continued focus on advancing treatments for rare immune-mediated diseases.

Sanofi | 02/03/2026 | By News Bureau

Duvakitug Shows Durable Efficacy in Ulcerative Colitis and Crohn's Disease in Long-Term Study

Long-term extension data show sustained remission and endoscopic response with duvakitug in ulcerative colitis and Crohn’s disease, strengthening its position as a potential next-generation TL1A therapy.

Sanofi | 18/02/2026 | By News Bureau |  180