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

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 ...

The FDA has started a priority review of Insmed's brensocatib, which is pitching to become the first approved therapy for ...

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, ...

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

According to the lawsuit, Sanofi has failed to provide partner Regeneron adequate information regarding the sales of Dupixent ...

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. According to the ...

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

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

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

Regeneron Pharmaceuticals beat fourth-quarter sales and profit estimates on Tuesday, on continuing demand for its eczema ...

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