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 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.
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.
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 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.
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.
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.
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.
The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously 10 to 0 to recommend routine use of Sanofi and AstraZeneca’s… read more.
Pivotal data from the Phase III XTEND-Kids study evaluating efanesoctocog alfa [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] once-weekly prophylaxis in previously treated patients younger than 12 years of… read more.
The FDA has approved Dupixent (dupilumab), from Sanofi + Regeneron, as an add-on maintenance treatment of patients aged 6 to 11 years with moderate-to-severe asthma characterized by an… read more.
The FDA has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) from Sanofi as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a… read more.
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