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FDA, Sanofi and Regeneron
Sanofi-Regeneron's Dupixent wins FDA's nod for 'smoker's lung'
The U.S. Food and Drug Administration has approved Sanofi and Regeneron's blockbuster drug Dupixent for patients with a chronic lung disease, commonly known as "smoker's lung", the companies said on Friday.
Regeneron-Sanofi Drug Wins FDA Approval To Treat COPD
Shares of Regeneron Pharmaceuticals and Sanofi edged higher Friday after their drug to treat chronic obstructive pulmonary disease received approval from the Food and Drug Administration.
Regeneron, Sanofi Get FDA OK for Dupixent to Treat COPD
Regeneron Pharmaceuticals and Sanofi have won FDA expanded approval of their blockbuster anti-inflammatory drug Dupixent in chronic obstructive pulmonary disease.
FDA approves Dupixent for adults with poorly controlled COPD
The FDA has approved Dupixent as an add-on maintenance treatment for adults with poorly controlled COPD and high counts of immune cells.
Sanofi, Regeneron look to seize major opportunity with Dupixent's COPD approval
After more than a decade without any therapeutic advancements in chronic obstructive pulmonary disorder (COPD), people with the progressive disease suddenly have two new options, with more likely o | Regeneron and Sanofi have announced that the FDA has expanded the label of megablockbuster Dupixent to treat COPD.
Regeneron/ Sanofi granted FDA label expansion for Dupixent in COPD
Regeneron (REGN) and Sanofi's (SNY) asthma therapy Dupixent receives FDA approval for label expansion in treating certain patients with COPD. Read more here.
FDA, after delay, clears Regeneron and Sanofi drug for COPD
Dupixent is the first biologic medicine approved in the U.S. for the common lung condition, though competitors from GSK, AstraZeneca and Roche could follow.
Sanofi/Regeneron’s Dupixent set to dominate COPD biologics market following FDA approval
Dupixent has gained positive opinions from KOLs due to the positive data presented from the asset’s two Phase III clinical trials.
FDA Approves Dupilumab as First Biologic Treatment for COPD
The FDA approved dupilumab today as the first biologic treatment for patients with uncontrolled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype to significantly help reduce exacerbations and improve lung function.
Regeneron, Sanofi blockbuster Dupixent wins FDA approval for COPD
Dupixent, commonly used to treat eczema and asthma, was cleared for a subset of patients with chronic obstructive pulmonary disease.
US FDA approves Sanofi-Regeneron's Dupixent for 'smoker's lung'
Sanofi recorded 10.72 billion euros ($11.94 billion) in sales for Dupixent in 2023, which includes Regeneron's share. Analysts on average expect Dupixent, by far Sanofi's best-selling drug, to generate more than 21 billion euros in sales in 2030,
FiercePharma
6d
Regeneron's stock drops as it loses bid to block Amgen's Eylea biosimilar
Three months after a federal judge in West Virginia sided with Regeneron, blocking the market entry of two biosimilars for ...
Pharmaceutical Technology
1h
Modalis wins FDA rare paediatric designation for CMD CRISPR therapy
Modalis Therapeutics has been awarded a rare paediatric disease designation by the US Food and Drug Administration (FDA) for ...
1d
Regeneron: Long-Term Defensive Investment
Regeneron's R&D expenses are projected to reach $5 billion, but the business remains highly profitable. Read why I rate REGN ...
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