The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.

Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.

Attorneys for the school district say that the legal action is in part due to self-funded insurance plans that has possibly ...

The FDA last year turned away the companies' application and asked for additional efficacy data. Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in ...

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ...

French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration ...

Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm ...

Sanofi said that Sarclisa, its treatment for plasma cell cancer, was recommended for EU approval by the European Medicines Agency. The agency's Committee for Medicinal Products for Human Use ...

As federal health scientists await a potential takeover by RFK Jr. and other medical skeptics in the second Trump ...

Healx will use its AI-based drug discovery tech to analyze proprietary Sanofi compound data and identify potential rare ...

After he stopped responding to several different therapies aimed at prolonging his life, doctors advised him to try a drug ...

Vera Therapeutics appointed Amgen and Seagen alum Matt Skelton as EVP of commercial. Frank Lane was appointed SVP and head of ...