Insys Therapeutics reaches an agreement in principle with the Department of Justice to pay $150 million to settle a civil and criminal investigation i...
FDA clears an iCAD 510(k) for its latest artificial intelligence software solution PowerLook Density Assessment Version 3.4 for breast density.
Texas attorney general Ken Paxton says AstraZeneca will pay the state $110 million to settle suits over fraudulent Medicaid marketing of its Seroquel ...
FDA issues a guidance with recommendations for submission of NDAs, INDs, or ANDAs for orally administered immediate-release drug products containing h...
FDA uses the Competitive Generic Therapy pathway to approve several strengths of Apotex potassium chloride solution.
FDA cautions healthcare professionals not to rely on rupture of membranes tests alone and instead use them as part of a broader clinical assessment.
Qiagen Sciences recalls the AmniSure ROM Test due to a potential manufacturing defect causing the control line to not display.
Federal Register notice: FDA withdraws 27 ANDAs from multiple applicants after the application holders told the agency that the drug products were no ...