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FDA approves MenQuadfi meningococcal vaccine for children 6 weeks or older – Sanofi

Written by | 3 Jun 2025

The FDA has approved an expanded indication of Sanofi’s quadrivalent meningococcal vaccine MenQuadfi—for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W,… read more.

Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria – Sanofi + Regeneron

Written by | 14 May 2025

The FDA has approved Dupixent (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1… read more.

FDA approves Merilog (insulin-aspart-szjj) the first rapid-acting insulin biosimilar product for treatment of diabetes – Sanofi

Written by | 20 Mar 2025

The FDA has approved Merilog (insulin-aspart-szjj) as biosimilar to NovoLog (insulin aspart) from Sanofi for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus…. read more.

New data from three oral presentations, showing significant clinical benefit with Sarclisa-based quadruplets in newly diagnosed multiple myeloma patients presented at ASH meeting – Sanofi

Written by | 11 Jan 2025

New data from three oral presentations, which demonstrated significant clinical benefit with Sarclisa-based quadruplets in newly diagnosed multiple myeloma (NDMM) patients were featured at the 66th American Society… read more.

FDA accepts resubmission of sBLA for Dupixent (dupilumab) for chronic spontaneous urticaria.- Regeneron + Sanofi

Written by | 22 Nov 2024

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the  FDA has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) to treat adults… read more.

The EMA has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one – Sanofi

Written by | 9 Nov 2024

The European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one year of age. Specifically, the approval covers children aged… read more.

Dupixent late-breaking positive phase III data in chronic spontaneous urticaria to be presented at ACAAI – Sanofi

Written by | 30 Oct 2024

Positive data from the phase III LIBERTY-CUPID Study C evaluating the investigational use of Dupixent (dupilumab) in biologic-naive patients with uncontrolled chronic spontaneous urticaria (CSU) who receive background… read more.

CHMP positive for Kevzara (sarilumab) to treat polymyalgia rheumatica – Sanofi

Written by | 27 Oct 2024

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Kevzara…. read more.

Sanofi Showcases Groundbreaking Beyfortus Data at IDWeek 2024, Highlighting Over 80% Effectiveness in Protecting Infants Against RSV

Written by | 18 Oct 2024

Sanofi advances its ambition to protect all infants from respiratory syncytial virus (RSV) disease with new Beyfortus (nirsevimab) data to be presented at the Infectious Disease Society of… read more.

Dupixent (dupilumab) approved in the EU as the first-ever targeted therapy for patients with COPD – Sanofi + Regeneron

Written by | 14 Jul 2024

The European Medicines Agency (EMA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils…. read more.

Kevzara (sarilumab) approved by FDA for the treatment of active polyarticular juvenile idiopathic arthritis – Regeneron + Sanofi

Written by | 10 Jul 2024

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has approved Kevzara (sarilumab) for the treatment of patients weighing 63 kg or greater with active polyarticular juvenile idiopathic… read more.

Dupixent provides late-breaking results showing reduced airway inflammation and mucus plugging in adults with uncontrolled moderate-to-severe asthma – Sanofi + Regeneron

Written by | 13 Mar 2024

Topline results from the VESTIGE Phase IV clinical trial evaluating the effect of Dupixent (dupilumab) on airway remodeling parameters through the use of functional respiratory imaging (FRI) in… read more.

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