Dupixent approved in the EU as the first-ever targeted therapy for patients with COPD
Dupixent positive phase 3 data in children one to 11 years of age with eosinophilic esophagitis published in NEJM
Majority of patients in this age group with eosinophilic esophagitis (EoE) receiving Dupixent achieved histologic remission, with improvements sustained up to one year Dupixent is the first and only...
Dupixent recommended for EU approval by the CHMP to treat patients with COPD Recommendation for adults with uncontrolled COPD with raised blood eosinophils based on data from two landmark Phase 3...
Update on FDA priority review of Dupixent for the treatment of COPD patients with type 2 inflammation Paris and Tarrytown, NY May 31, 2024. The US Food and Drug Administration (FDA) has...
J&J acquires experimental skin disorder drug for $1.25 billion
NOTUS results confirm landmark data from the Phase 3 BOREAS trial and show Dupixent significantly reduced exacerbations by 34% and improved lung function, compared to placebo, in uncontrolled chronic...
TARRYTOWN, N.Y. and PARIS, May 13, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). The target action date for the FDA decision is September 15, 2024. Dupixent is currently approved as an add-on maintenance treatment for adults with CRSwNP whose disease is not adequately controlled.
TARRYTOWN, N.Y. and PARIS, May 13, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). The target action date for the FDA decision is September 15, 2024. Dupixent is currently approved as an add-on maintenance treatment for adults with CRSwNP whose disease is not adequately controlled.
New positive data from an additional analysis of dupilumab-experienced patients treated with eblasakimab 400mg, weekly over 16 weeks further support the recent finding that some AD patients may...