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SNY Jun 2024 47.500 call
- 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.
- Zacks
Pharma Stock Roundup: JNJ, MRK M&A Deals, SNY, RHHBY Drugs' Priority Review & More
J&J (JNJ) and Merck (MRK) announce the acquisitions of private biotechs. The FDA grants Priority Review tags to Sanofi's (SNY) and Roche's (RHHBY) regulatory applications.
