The FDA has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility ...
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 ...
Sanofi’s jump in earnings comes with an increased emphasis on R&D and vaccines, plus an eye cast toward M&A to shore up its pipeline.
The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.
A new FDA warning letter for French pharmaceutical company Sanofi cited a handful of issues at its biologics factory in ...
The FDA issues a warning letter to Sanofi over manufacturing violations at its Massachusetts site, citing contamination 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 ...
The drugs’ active ingredient, glatiramer acetate, has been linked to more than 80 cases of anaphylaxis worldwide since ...
After hitting a regulatory roadblock in 2022, Sanofi’s consumer healthcare business Opella has secured the FDA’s blessing to ...