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- Benzinga
Zantac Heart Burn Continues For GSK As US Court Ruling Allows Thousands Of Zantac Lawsuits To Move Forward
On Monday, GSK Plc (NYSE:GSK) shares were down after the Delaware State Court ruled that more than 70,000 lawsuits could proceed over its discontinued heartburn drug, Zantac (ranitidine). The State Court’s decision contradicts the Federal Court’s Multidistrict Litigation ruling under the same legal standard, which dismissed all cases alleging five cancer types in December 2022. GSK says the litigation in Delaware remains at an early stage, and the ruling, under the Daubert standard, relates only
- 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.
