"At the end of the inspection, a 'Form 483' has been issued with 9 observations. With respect to the mentioned inspection, we have received a letter from USFDA classifying the inspection as ...

HERLEV, Denmark, Nov. 11, 2024 /CNW/ -- Nordic Bioscience, a leading biomarker company, announced that its CPa9-HNE biomarker assay received a Letter of Support (LoS) from the U.S. Food and Drug ...

Abeona Therapeutics (ABEO) announced the FDA has accepted for review resubmission of Biologics License Application for prademagene ...

The U.S. Food and Drug Administration is taking North Chicago-based drugmaker AbbVie to task, warning in a recent letter that ...

The FDA issued the letter on August 9, and has given the company 15 days to respond. The company could not be reached for comments over the FDA letter. Advisory Alert: It has come to our attention ...

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HERLEV, Denmark, Nov. 11, 2024 /CNW/ -- Nordic Bioscience, a leading biomarker company, announced that its CPa9-HNE biomarker assay received a Letter of Support (LoS) from the U.S. Food and Drug ...

Nordic Bioscience has a strong history in ECM remodeling research, earning FDA Letters of Support for its PRO-C3 and PRO-C6 biomarkers. The Company has transferred the FDA-approved bone biomarker ...