Genzyme said in a Sanofi statement it had received an FDA 'complete response letter', to which it would appeal. Its president and chief executive was " extremely disappointed with the outcome of ...
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 ...
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 ...
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 ...
Also Read: Sanofi Genzyme Facility Draws FDA Criticism Over Alleged Quality Lapses An independent data monitoring committee ...
Fitusiran (ALN-AT3) is a subcutaneously administered, investigational RNAi therapeutic targeting antithrombin (AT) in ...
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 ...