THURSDAY, Jan. 23, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has warned the pharmaceutical company Sanofi about significant deviations from Current Good Manufacturing Practice ...
More than three years after approving two biosimilars referencing Sanofi’s long-acting insulin Lantus, the FDA has signed off on a rapid-acting insulin biosimilar for the first time. The agency ...
On Jan. 15, 2025, a warning letter was sent to Sanofi stating that FDA inspectors found irregularities with the facility’s bioreactor, the vessel used to grow organisms and cells. According to ...
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