Sanofi Secures CHMP Positive Opinion for Cenrifki (Tolebrutinib) in Non-Relapsing SPMS Despite FDA Complete Response Letter Setback
Sanofi (NASDAQ: SNY) announced on 24 April 2026 that the European Medicines Agency’s Committee for...
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FDA Expands Sanofi’s Tzield Approval to Children as Young as One Year Old for Type 1 Diabetes Prevention
The U.S. Food and Drug Administration (FDA) has approved a supplemental biologics license application for...
FDA Approves Sanofi-Regeneron’s Dupilumab for Pediatric Chronic Spontaneous Urticaria in Children Aged 2–11 Years
The U.S. Food and Drug Administration (FDA) has granted approval to Sanofi (NASDAQ: SNY) and...
FDA Extends Review Timeline for Sanofi’s Sarclisa Subcutaneous Formulation by Three Months; New Decision Date Set for July 23, 2026
The U.S. Food and Drug Administration (FDA) has extended the target action date for its...
China’s NHSA Selects 31 Innovative Drugs for Historic Reference Drug Pre-Communication Program
The National Healthcare Security Administration (NHSA) has published the inaugural list of 31 innovative drugs...
Sanofi Secures EC Approval for Dupixent in Pediatric Chronic Spontaneous Urticaria – First Biologic Therapy for Children 2–11 Years
Sanofi SA (NASDAQ: SNY) announced that the European Commission (EC) has granted marketing authorization for...
Sanofi’s Bispecific Nanobody Lunsekimig Achieves Primary Endpoints in Asthma and CRSwNP Phase II Studies, Shows Mixed Results in Atopic Dermatitis
Sanofi (NASDAQ: SNY) announced positive top-line results from two Phase II clinical studies of lunsekimig,...
Sanofi Secures EU Conditional Approval for Rezurock in Chronic Graft-Versus-Host Disease
Sanofi (NASDAQ: SNY) announced that the European Commission (EC) has granted conditional marketing authorization for...
Sanofi’s Dupixent Wins Japan Approval for Bullous Pemphigoid – Seventh Indication Expands IL‑4/IL‑13 Franchise
Sanofi S.A. (NASDAQ: SNY) announced that Dupixent (dupilumab) has received marketing approval from Japan’s Ministry...
Kali Therapeutics Licenses KT501 to Sanofi – $1.23B Deal for Trispecific T-Cell Engager Targets Autoimmune Diseases
Kali Therapeutics announced a licensing agreement with Sanofi (NASDAQ: SNY) for KT501, a novel trispecific...
Sanofi Upgrades Shanghai R&D Center to Legal Entity – Largest China Translational Medicine Hub Anchors Global Network
Sanofi S.A. (NASDAQ: SNY) announced a comprehensive strategic upgrade of its China R&D center, establishing...
Sanofi Opens Chengdu Innovation Hub – 600‑Headcount China Operations Center to Drive R&D and Commercial Excellence
Sanofi S.A. (NASDAQ: SNY) has officially opened its China Innovation and Operations Hub in Chengdu,...
Sanofi’s Venglustat Wins FDA Breakthrough Therapy Designation – Oral Brain-Penetrant GCSi Targets Gaucher Disease Type 3 Neurological Symptoms
Sanofi (NASDAQ: SNY) announced that venglustat received Breakthrough Therapy Designation (BTD) from the U.S. Food...
Sino Biopharma Licenses Rovadicitinib to Sanofi in $1.53B Deal – First‑in‑Class JAK/ROCK Inhibitor Goes Global
Sino Biopharmaceutical Ltd (HKG: 1177) announced a licensing agreement with Sanofi SA (NASDAQ: SNY) for rovadicitinib, a...
Sanofi’s Rilzabrutinib Wins Japan Orphan Designation for IgG4‑RD – BTK Inhibitor Expands Rare Disease Portfolio
Sanofi (NASDAQ: SNY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted orphan...
Dupixent Wins Two NMPA Approvals in China – First Biologic for Bullous Pemphigoid and Pediatric Asthma Expansion
Sanofi (NASDAQ: SNY) announced that Dupixent (dupilumab) has been approved by China’s National Medical Products Administration...
Dupixent Wins CHMP Positive Opinion for Pediatric CSU – EU Approval Nears for Children Aged 2–11 Years
Sanofi (NASDAQ: SNY) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human...
Dupixent Wins FDA Approval for Allergic Fungal Rhinosinusitis – First Targeted Therapy for AFRS Expands Dupilumab Label
Sanofi (NASDAQ: SNY) and Regeneron (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has...
Sanofi Appoints Belén Garijo as New CEO to Drive R&D Innovation and Productivity
Sanofi (NASDAQ: SNY) announced a leadership transition, with Paul Hudson stepping down as Chief Executive Officer...
Sanofi Invests $30 Million in GluBio’s Sickle Cell TPD Programs
GluBio Pharmaceutical Co., Ltd., a Zhejiang-based molecular glue targeted protein degradation (TPD) specialist, announced a...