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

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, ...

The FDA says that food companies will have until Jan. 15, 2027 to stop using the dye. Drugmakers will have an extra year, until January 2028, to comply with the change. Red 3, also known as ...

New FDA Consultant is the former Director of the Division of Imaging ... C.R Bard, Smiths Medical, ACMI, Genzyme, Pfizer Hospital Products, and various start-ups. He is the former VP of Regulatory ...

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 ...

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 ...

Mesoblast (ASX:MSB) was the top performer for the year up 835% (as of December 30). On December 18 Mesoblast announced that the US Food and Drug Administration (FDA) had finally approved its therapy ...

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 are now moving towards refilling its FDA application for its other MS drug, Lemtrada. "We are on track to satisfy the questions of navigability from the FDA. We are also having ...