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In a loss for Sanofi and Regeneron, a federal judge upheld a jury verdict validating two of Amgen’s cholesterol drug patents for Repatha, denying a request to overturn the judgment and launch a new trial. Read More
Unrestricted access to electronic records and a series of quality control deficiencies resulted in a seven-observation 483 for a specialty drugmaker based in Maryland. Read More
FDAnews has compiled a list of the 21st Century Cures Act’s requirements and deadlines most relevant to the FDA and the pharmaceutical industry, including upcoming guidances, policies and public reports. Read More
The FDA plans to conduct two studies to gauge whether consumers and healthcare professionals have the capacity to detect and report deception prescription drug advertisements. Read More
Wockhardt is in hot water with the FDA again, receiving another warning letter for significant GMP violations regarding quality and data controls. Read More