Straits Times Index
3,336.59 +13.21 (+0.40%) Nikkei
38,487.90 +433.80 (+1.14%) Hang Seng
18,079.61 -150.59 (-0.83%) FTSE 100
8,276.46 +45.41 (+0.55%) Bitcoin USD
67,367.60 -910.40 (-1.33%) CMC Crypto 200
1,416.44 -12.13 (-0.85%)
REGN Jan 2025 880.000 put
- Benzinga
FDA Extends Review Deadline For Regeneron/Sanofi's Dupixent For 'Smoker's Lungs' Disease
On Friday, the FDA extended the target action date of priority review of supplemental application seeking approval for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD), a lung disease that’s usually caused by smoking. The revised target action date is September 27, 2024. The FDA accepted the application in February, with a target action date of June 27, 2024. The FDA did not raise any concerns regardi
- Zacks
FDA Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD
Per the FDA, the data submitted by Sanofi (SNY)/Regeneron (REGN) for Dupixent in COPD indication constitutes a major amendment to its previously-submitted data. A final decision is expected by Sep 27.
- GlobeNewswire
Dupixent® (dupilumab) 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 trials demonstrating Dupixent significantly reduced exacerbations and improved lung function If approved, Dupixent would be the first-ever targeted therapy for COPD in the EU and the first new treatment approach for this disease in more than a decade TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announ
