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 ...
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 U.S. drug ingredients plant tied to its longstanding subsidiary Genzyme.
Sanofi and J&J halted a phase 3 E. coli vaccine trial due to insufficient efficacy. Sanofi's Q4 2024 IFRS EPS dropped by ...
Red 3 – also called FD&C Red No. 3, erythrosine or E127 – has been widely used in food, cosmetics and pharmaceuticals since its FDA approval in 1969. You’ve likely encountered Red 3 before.
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 ...
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 ...
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