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 ...

If it’s published, the FDA is expected to propose language noting that “these chemicals are used in certain cosmetic products that are applied to human hair as part of a combination of ...

Genzyme ran into a snag in April when the US Food and Drug Administration (FDA) rejected its application to produce Myozyme (alglucosidase alfa, rhGAA) in its 2,000–liter-scale facility under ...

Also Read: Sanofi Genzyme Facility Draws FDA Criticism Over Alleged Quality Lapses An independent data monitoring committee ...

THURSDAY, Jan. 23, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has warned ... for active pharmaceutical ingredients at their Genzyme manufacturing plant in Framingham ...

Genzyme became a subsidiary of Sanofi and kept ... Biggest Boston biotech news coming out of JPM 2025 Hologic gets FDA warning regarding implantable devices Hologic gets FDA warning regarding ...

Fitusiran (ALN-AT3) is a subcutaneously administered, investigational RNAi therapeutic targeting antithrombin (AT) in ...

Although Genzyme also produces Myozyme (alglucosidase alpha) at the plant, no runs were scheduled during the presumed period of shutdown so supplies of that drug will not be affected. With sales ...