The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
After years of limited advancements in chronic obstructive pulmonary disease (COPD) treatment, patients now have new options.
The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...
After a long road that included a three-month delay as the agency pushed for additional data, the US FDA has approved Sanofi and Regeneron's Dupixent (dupilumab) for COPD - as has China's National ...
Regeneron released a strong financial report for Q3 and was the 15th of 16 in the last four years. Read why I upgrade REGN ...
Apogee Therapeutics' APG777 shows promise in treating atopic dermatitis with less frequent dosing. See why I rate APGE stock ...
Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 ...
Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark Phase 3 trials showing Dupixent significantly reduced exacerbations ...
The BOREAS Phase III trial showed DUPIXENT reduced exacerbations by 30% and improved lung function by 160 mL at 52 weeks. Approximately 44 million COPD cases were recorded in 2023 in the 7MM ...
chronic spontaneous urticaria (CSU), and chronic obstructive pulmonary disease (COPD) in different age populations. More than 1,000,000 patients are being treated with Dupixent globally.