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 ...
The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.
Sanofi said on Thursday it would buy back 5 billion euros ($5.21 billion) in shares this year and could be more active with acquisitions in the near term as the drugmaker moves towards selling a large ...
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 ...
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.
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.
Sanofi's Consumer Healthcare division, Opella, announced that the U.S. Food and Drug Administration has lifted a clinical hold on its ...
Also Read: Sanofi’s Blood Cancer Drug’s New Subcutaneous Formulation Hits Primary Goal In Late-Stage In Multiple Myeloma The facility’s quality unit was also scrutinized for its inability to ...