The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.
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.
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, ...
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 ...
Companies say they are working to update their products to comply with the Food and Drug Administration's decision Wednesday to ban the artificial food dye Red 3, after the agency said it was ...
Jan. 14 (UPI) --The U.S. Food and Drug Administration hopes "front-of-package" labeling will better improve the American population's health, the FDA announced. "Food should be a vehicle for ...
Even quaint corners of the country are seeing a rise in drug violence and crime. Just ask the mayor of Morlaix, which has a population of about 15,000. By Richard Fausset Reporting from Morlaix ...
You might just know someone, close or distant, who has struggled with drug addiction at one point in time. It could be a distant relative or someone you went to school with, but the sheer probability ...
The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new small molecules, biologics and oligonucleotide therapeutics last year. The class of 2024 was a little smaller than that ...
Substance abuse in the United States is one of the leading health conditions impacting millions of lives and due to many types of drug addictions. Since 2000, there have been 700,000 overdose deaths ...
The FDA has cleared their once-weekly Factor VIII ... of the week,” according to Bill Sibold – head of the Sanofi Genzyme unit, which will be responsible for marketing the new drug – who ...
Genzyme, a subsidiary of Sanofi, has announced key data from its phase 3 clinical trials of its multiple sclerosis drug, Aubagio. The trials, called TOWER (Teriflunomide Oral in people With ...