Approval in adults and children aged 6 years and older supported by Phase 3 trial demonstrating Dupixent significantly reduced nasal signs and symptoms, and systemic corticosteroid use or surgery ...

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive ...

Sanofi (ENXTPA:SAN) received FDA approval for Dupixent as the first and only treatment for allergic fungal rhinosinusitis, expanding its use into a new indication. The company also appointed Belén ...

Approval based on pivotal results showing improvements in sustained disease remission and reductions in itch and oral corticosteroid use compared to placebo in adults with BP BP is a chronic, ...

Approval based on pivotal results showing improvements in sustained disease remission and reductions in itch and oral corticosteroid use compared to placebo in adults with BP BP is a chronic, ...

Regeneron Pharmaceuticals REGN and its partner Sanofi SNY announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion ...

Dupixent meets early efficacy threshold for continuation in ongoing Phase 3 trial of patients with COPD; second confirmatory trial will commence in third quarter of 2020 Regeneron Pharmaceuticals, Inc ...

Dupixent (dupilumab) has been a breakthrough treatment for people with severe eczema, asthma, and other inflammatory conditions. For many, it has provided relief when other therapies failed. However, ...

Approval based on global Phase 3 program in children demonstrating Dupixent significantly reduced exacerbations (by 54% to 65%) and improved lung function (by 4.68% to 5.32%) compared to placebo ...

Priority Review approval extends dupilumab into AFRS with prior surgery, expanding sino-nasal indications beyond CRSwNP and representing the ninth FDA-approved indication across type 2 inflammatory ...