The European Medicines Agency (EMA) has granted approval for Dupixent, a therapy developed by Sanofi and Regeneron, to treat eosinophilic esophagitis (EoE) in children as young as one year old. This decision marks a critical step in addressing a condition that has left young patients and their families with limited options. With this approval, Dupixent […]
Eupraxia Pharmaceuticals Inc., listed on both TSX and NASDAQ under the ticker EPRX, has revealed encouraging results from its ongoing Phase 1b/2a RESOLVE trial. The trial is evaluating EP-104GI, a new treatment for eosinophilic esophagitis (EoE), utilizing the company’s proprietary DiffuSphere technology. Trial Results Show Efficacy and Safety The latest data from the RESOLVE trial’s […]
French pharmaceutical company Sanofi and Regeneron, an American biotechnology company, have received the approval of the European Commission (EC) to market their Dupixent (dupilumab) injection in the European Union for eosinophilic esophagitis (EoE). Dupixent is indicated in adults and adolescents 12 years and over, who are not candidates for conventional medicinal treatment. With the approval, […]
The US Food and Drug Administration (FDA) has refused to approve the supplemental biologics license application (sBLA) of AstraZeneca’s asthma drug Fasenra (benralizumab) for the treatment of patients having inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). The US pharma regulator has issued a complete response letter (CRL) to AstraZeneca, seeking more clinical data on […]
Regeneron Pharmaceuticals and Sanofi said that their co-developed eczema drug Dupixent (dupilumab) has met the co-primary endpoints of Part A of a phase 3 trial in patients 12 years and older who have eosinophilic esophagitis (EoE). The late-stage trial also all the key secondary endpoints. Dupixent is now the first and only biologic to demonstrate […]