Articles from Sanofi Winthrop Industrie

Sanofi and Regeneron’s Dupixent recommended for EU approval to treat chronic spontaneous urticaria in young children with ongoing symptoms despite treatment

Acoziborole Winthrop, developed by DNDi and Sanofi, receives CHMP positive opinion as three-tablet, single-dose treatment for most common form of sleeping sickness 

Sanofi and Regeneron’s Dupixent approved in the US as the first and only medicine for allergic fungal rhinosinusitis

Filing of the 2025 U.S. Form 20-F and French “Document d’Enregistrement Universel” containing the Annual Financial Report

Sanofi and Teva’s duvakitug phase 2b maintenance data demonstrated clinically meaningful durable efficacy in ulcerative colitis and Crohn’s disease

Beyfortus study published in The Lancet Infectious Diseases shows benefit for infants beyond first RSV season

Belén Garijo to become Chief Executive Officer of Sanofi

Sanofi completes the acquisition of Dynavax

Sanofi’s rilzabrutinib designated breakthrough therapy in the US and orphan drug in Japan for the treatment of warm autoimmune hemolytic anemia

Sanofi announces the signing of a share buyback mandate for up to €1 billion

  

Sanofi’s Rezurock recommended for EU approval by the CHMP to treat chronic graft-vs-host disease

Sanofi's amlitelimab confirms its potential in atopic dermatitis

Myqorzo and Redemplo approved in China

Sanofi’s Teizeild approved in the EU for patients with stage 2 type 1 diabetes

Sanofi’s Tzield accepted for priority review in the US for young children with stage 2 type 1 diabetes

Sanofi to acquire Dynavax, adding a marketed adult hepatitis B vaccine and phase 1/2 shingles candidate to the pipeline

Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis

Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia

Sanofi and Regeneron’s Dupixent approved in Japan for children aged 6 to 11 years with bronchial asthma

Sanofi reaches agreement with the US government to lower medicine costs while strengthening innovation

Availability of the Q4 2025 Aide memoire

Sanofi’s efdoralprin alfa earns orphan designation in the EU for alpha-1 antitrypsin deficiency related emphysema

Sanofi provides update on tolebrutinib in primary progressive multiple sclerosis

Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis

Sanofi’s Qfitlia and Cablivi approved in China, expanding care for rare diseases

Sanofi and Regeneron’s Dupixent approved as the first targeted medicine in the EU in over a decade for chronic spontaneous urticaria

Sanofi’s Teizeild recommended for EU approval by the CHMP for patients with stage 2 type 1 diabetes

ACAAI: Sanofi and Regeneron’s Dupixent pivotal study met all primary and secondary endpoints, reducing signs and symptoms of allergic fungal rhinosinusitis; sBLA accepted for FDA priority review

Sanofi successfully prices USD 3 billion of bond issue  

Sanofi’s efdoralprin alfa met all primary and key secondary endpoints in alpha-1 antitrypsin deficiency emphysema phase 2 study

Sanofi’s Tzield accepted for expedited review in the US for stage 3 type 1 diabetes through FDA Commissioner's National Priority Voucher pilot program

Sanofi’s high-dose influenza vaccine demonstrates superior protection for older adults against hospitalization vs standard-dose

Sanofi’s Wayrilz recommended for EU approval by the CHMP to treat immune thrombocytopenia

Sanofi provides update on regulatory review in the EU for Rezurock to treat chronic graft-vs-host disease

AlphaMedixTM (212Pb-DOTAMTATE) achieved all primary efficacy endpoints in phase 2 study, demonstrating clinically meaningful benefits in patients with gastroenteropancreatic neuroendocrine tumors

Sanofi commits an additional $625 million to Sanofi Ventures to accelerate investment in biotech and digital health innovation

 

Sanofi’s SAR446268 earns US fast track designation for the treatment of non-congenital myotonic dystrophy type 1

Update on the US regulatory review of tolebrutinib in non-relapsing, secondary progressive multiple sclerosis

Sanofi and Regeneron’s Dupixent to treat chronic spontaneous urticaria advances in EU with positive CHMP opinion

EADV: Sanofi’s brivekimig achieved positive results in hidradenitis suppurativa in phase 2a study

Sanofi’s SAR402663 earns fast track designation in the US for neovascular age-related macular degeneration

Tzield approved in China as first disease-modifying therapy for adult and pediatric patients with stage 2 type 1 diabetes        

Sanofi’s amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic dermatitis

Sanofi’s Wayrilz approved in US as first BTK inhibitor for immune thrombocytopenia

Sanofi’s rilzabrutinib earns orphan designation in the EU for IgG4-related disease

Sanofi completes the acquisition of Vigil Neuroscience, Inc.

Online availability of Sanofi’s half-year financial report for 2025

Q2: double-digit sales and solid business EPS growth. 2025 sales guidance is now high single-digit growth, at upper end of range

Sanofi’s SAR446523, a GPRC5D monoclonal antibody, earns orphan drug designation in the US for multiple myeloma

Sanofi’s Sarclisa approved in the EU for the treatment of transplant-eligible newly diagnosed multiple myeloma

Sanofi to acquire Vicebio, expanding respiratory vaccines pipeline

Sanofi completes acquisition of Blueprint Medicines

Sanofi announces extension of Blueprint tender offer

Sanofi’s SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration

 

Riliprubart granted orphan drug designation in Japan for chronic inflammatory demyelinating polyneuropathy

Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation

Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma

Dupixent approved in the US as the only targeted medicine to treat patients with bullous pemphigoid

 

EAACI: Dupixent demonstrated superiority over Xolair (omalizumab) in chronic rhinosinusitis with nasal polyps in patients with coexisting asthma in first-ever presented phase 4 head-to-head respiratory study

Sanofi accelerates global shipping of Beyfortus to prepare healthcare providers months ahead of 2025-2026 RSV season

Sanofi Launches 2025 Global Employee Stock Purchase Plan

ASCO: new Sarclisa data support subcutaneous administration with on-body injector

Rilzabrutinib granted orphan drug designation in the US for sickle cell disease

Itepekimab met the primary endpoint in one of two COPD phase 3 studies

Beyfortus public health advantage bolstered by first real-world comparison of infant vs maternal RSV immunization programs

Sanofi completes acquisition of DR-0201