The U.S. Food and Drug Administration has warned the pharmaceutical company Sanofi about significant deviations from Current ...

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 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, ...

Genzyme of Cambridge, Massachusetts, faces millions in lost revenue from its top-selling specialty drugs Cerezyme and Fabrazyme as result of a viral contamination at its Allston, Massachusetts plant.

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

20% of bioreactor runs at the Genzyme facility failed due to contamination or quality issues over 2.5 years. FDA identified 84 overdue deviation investigations, some exceeding 180 days ...

Sanofi has finally settled a long-running dispute with shareholders in the biotech Genzyme, who claimed the big pharma deliberately held back development of a multiple sclerosis drug to avoid ...

Although Genzyme has no equity stake in Osiris, which will keep all US and Canadian rights to its MSC products and indications, the Cambridge, Massachusetts–based company does get commercial ...