This growth comes on the back of a steady market performance from 2017 to 2022, where the injection pen sector achieved a ...

Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid If approved, Dupixent would be the first and only targeted medicine to treat BP in the US; FDA ...

Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the supplemental biologics license application for Dupixent to treat adults with bullous pemphigoid.

Regeneron Pharmaceuticals and Sanofi have won Food and Drug Administration priority review of their application seeking expanded approval of their blockbuster anti-inflammatory drug Dupixent for ...

If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S.; FDA decision expected by June 20, 2025 Priority Review granted based on positive pivotal results ...

The sBLA is supported by data from a pivotal trial evaluating the efficacy and safety of Dupixent in 106 adults with moderate-to-severe BP. The primary endpoint was met, with five times more ...

Regeneron and Sanofi have collaborated on Dupixent since 2007. Credit: The Washington Post via Getty Images. Sanofi and Regeneron’s blockbuster biologic Dupixent (dupilumab) is poised for yet another ...

The approval is for both a 3 milliliter single-patient-use prefilled pen and a 10 milliliter multiple-dose vial. Merilog is the third insulin biosimilar product approved by the FDA and joins the ...