Breakthrough EU approval for Dupixent offers new hope for children with eosinophilic esophagitis

Breakthrough EU approval for Dupixent offers new hope for children with eosinophilic esophagitis

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 announces promising results for EP-104GI in eosinophilic esophagitis trial

Eupraxia Pharmaceuticals announces promising results for EP-104GI in eosinophilic esophagitis trial

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 […]

Sanofi, Regeneron get Dupixent EC approval for eosinophilic esophagitis

Sanofi, Regeneron get Dupixent EC approval for eosinophilic esophagitis

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, […]

FDA refuses to approve AstraZeneca’s sBLA for Fasenra in CRSwNP

FDA refuses to approve AstraZeneca’s sBLA for Fasenra in CRSwNP

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 […]