The Justice Department says a former McKinsey executive pleaded guilty to knowingly destroying information central to the governments case against the...
FDA approves Eli Lillys Omvoh (mirikizumab-mrkz) for treating moderately to severely active Crohns disease in adults.
FDA accepts for review a Johnson & Johnson NDA for TAR-200 (gemcitabine), an intravesical drug releasing system for treating certain patients with Bac...
Getinge and its subsidiary Maquet Cardiovascular recall the VasoView HemoPro 2 (VH-4000 and VH-4001) Endoscopic Vessel Harvesting Systems due to the p...
Federal Register notice: FDA withdraws approval of 23 ANDAs from multiple applicants after they told the agency that the drug products were no longer ...
FDA proposes to deny a Vanda NDA for tradipitant and offers the company an opportunity to seek a commissioners hearing on the denial.
FDA warns Integra Lifesciences about Quality System Regulation violations in the manufacturing of neurological and neurosurgical medical devices at th...
FDA warns Marlborough, MA-based Hologic about Quality System and Medical Device Reporting violations in its production of implantable radiographic mar...
