Dupixent has been approved for CSU in Japan and the United Arab Emirates (UAE) and is also under regulatory review in the European Union based on earlier trial readouts. Outside of Japan and the ...
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 ...
The US Food and Drug Administration (FDA) has accepted for review the resubmitted supplemental Biologics License Application (sBLA) for Sanofi and Regeneron’s Dupixent (dupilumab) in chronic ...
Dupixent (dupilumab) was the first biologic ... Dermavant and its topical psoriasis therapy Vtama, which is also under review by the FDA for atopic dermatitis. Join the conversation, on Tuesday ...
Dupixent (dupilumab) is a prescription drug that’s used to treat certain inflammatory conditions. The drug comes as a solution for injection under the skin. How often you’ll receive a dose ...
Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in CSU, which causes sudden and debilitating hives and recurring itch. The companies said an ...
Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License Application, or sBLA, for Dupixent to treat adults and ...
The FDA has accepted the resubmitted sBLA for Regeneron/Sanofi's Dupixent to treat CSU in patients aged 12+ unresponsive to H1 antihistamine Dupixent's resubmission is backed by LIBERTY-CUPID ...
Dupixent is already approved for the CSU indication in Japan while it is under review in the EU. Dupixent is now approved in several countries, including the United States and EU, for six type II ...