The FDA has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility in Massachusetts.

Immunology superstar Dupixent, which first brought Regeneron and Sanofi together in 2007, has entered its megablockbuster era ...

The FDA issues a warning letter to Sanofi over manufacturing violations at its Massachusetts site, citing contamination and inadequate quality controls. The agency demands a comprehensive review, ...

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 ...

A new FDA warning letter for French pharmaceutical company Sanofi cited a handful of issues at its biologics factory in ...

Sanofi-Aventis US LLC filed a lawsuit against the Department of Health and Human Services (HHS) and the Health Resources and ...

The FDA issued a warning letter to Sanofi regarding significant manufacturing violations at its Genzyme Corporation Facility in Framingham, Mass. The letter, dated Dec. 16, 2024, and amended Jan. 15, ...

Sanofi’s (NASDAQ:SNY) consumer healthcare unit Opella announced Tuesday that the U.S. FDA has lifted a clinical hold on a trial designed to test an over-the-counter version of its erectile dysfunction ...

While Sanofi’s immunology megablockbuster Dupixent predictably dominated the company’s sales charts in 2024, a new golden ...

The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.

On Jan. 15, 2025, a warning letter was sent to Sanofi stating that FDA inspectors found irregularities with the facility's bioreactor, the vessel used to grow organisms and cells.