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 ...

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 ...

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

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 ...

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

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 ...

Ozempic, the blockbuster GLP-1 drug that was originally approved to treat type 2 diabetes, has now also been approved by the US Food and Drug Administration to reduce certain risks associated with ...

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 ...