The FDA is to review Sanofi/Regeneron's Dupixent as a treatment for asthma, a new use that could more than double its sales following its previous approval for eczema. Analysts predict peak annual ...

Immunology superstar Dupixent, which first brought Regeneron and Sanofi together in 2007, has entered its megablockbuster era. But even as the billions pile up, Regeneron isn't entirely happy with ...

(NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent ® ...

The US regulator has approved Sanofi/Regeneron’s Dupixent (dupilumab) in a new asthma indication, a key step in the companies attempt to build a blockbuster franchise around the drug.

As Sanofi and Regeneron await the FDA decision, a legal dispute between the partners over commercialisation details continues ...

Paris and Tarrytown, NY, February 18, 2025. The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to ...

Adverse events more commonly observed with Dupixent (in at least 3 patients) compared to placebo included peripheral edema, arthralgia, back pain, blurred vision, hypertension, asthma ...

The FDA approval is still pending, creating uncertainty around the market acceptance and commercial ... older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps ...

Dupixent was previously granted Orphan Drug Designation by the FDA for BP, which applies to investigational medicines intended for the treatment of rare diseases that affect fewer than 200,000 ...

Do not change or stop your other medicines, including corticosteroid medicine or other asthma ... Dupixent® (dupilumab); the likelihood, timing, and scope of possible regulatory approval and ...