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

Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a ...

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

After hitting a regulatory roadblock in 2022, Sanofi’s consumer healthcare business Opella has secured the FDA’s blessing to ...

French pharmaceutical giant Sanofi has received a warning letter from the U.S. Food and Drug Administration following an inspection at its drug manufacturing facility in Framingham. French ...

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

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 ...

Sanofi’s (SNY) said FDA lifted a hold on a trial to test over-the-counter use of its Eli-Lilly (LLY)-partnered erectile dysfunction ((ED)) drug, Cialis. Read more here.

Sanofi's Consumer Healthcare division, Opella, announced that the U.S. Food and Drug Administration has lifted a clinical hold on its ...

The FDA also found Genzyme’s proposed corrective and preventive actions (CAPAs) insufficient. Sanofi must respond within 15 working days, outlining its corrective measures and provide the FDA ...

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 ...