FDA says a Medtronic recall of its HVAD pump implant kit due to a pump weld defect is Class 1.
FDA says it is considering implementing a master file pilot program for PMA holders whose approved devices are sterilized using radiation.
Federal Register notice: FDA posts a list of PMAs that have been approved from 1/1/2021 through 2/14/2022 that have safety and effectiveness summaries...
FDA approves a Novo Nordisk NDA for Wegovy (semaglutide) injection (2.4 mg once weekly) for treating adults with obesity or who are overweight with at...
FDA releases the FDA-483 with seven observations from an inspection at West Columbia, SC-based Nephron Sterile Compounding Center.
The CDER Office of Prescription Drug Promotion cautions Althera that a professional promotion for its cholesterol-lower drug Roszet contains false and...
Four senators sponsor bipartisan legislation to speed some interchangeable biologics to market.
A former employee at Eli Lilly files a wrongful termination suit against the pharmaceutical manufacturer, claiming she was fired in retaliation for ra...