FDA awards five grants for improvements to continuous manufacturing of biological products.
Getinge begins a field correction on about 5,223 Maquet/Getinge Cardiosave intra-aortic balloon pumps due to a potential interruption or inability to ...
FDA disputes findings published in the Annals of Surgery that suggested an increased risk of certain connective tissue conditions, such as rheumatoid ...
Janssen Pharmaceutical files an NDA seeking approval of erdafitinib for treating certain patients with locally advanced or metastatic urothelial cance...
California files a lawsut against AbbVie alleging that it gave illegal kickbacks to health care providers to prescribe Humira (adalimumab), indicated ...
After a decade of stonewalling injured patients complaints about adverse reactions to LASIK vision-therapy laser surgeries, CDRH lifts their hopes for...
Federal Register notice: FDA corrects an incorrect docket number appearing in a 9/11 Federal Register notice entitled Post-approval Changes to Drug Su...
FDA issues one draft and two final guidances explaining provisions of the Drug Supply Chain Security Act relating to drug product identifiers.