FDA commissioner Robert Califf tells a Senate appropriations hearing that FDA and CMS are working to make sure clinical trials for products seeking ac...
DBV Technologies receives written responses from FDA after a pre-BLA meeting in February about the regulatory path for investigational Viaskin Peanut ...
BelGene says its tislelizumab with chemotherapy met the primary endpoint of overall survival in patients with some gastric cancers in the Phase 3 RATI...
FDA warns Tlalnepantla, Mexico-based Zermat International about repeat CGMP violations in its manufacturing of over-the-counter drugs.
Fresenius Kabi recalls its Ivenix Infusion System due to a leak in the device that allows fluid to enter the administration set loading area.
Federal Register notice: FDA seeks comments on an information collection extension entitled Rapid Response Surveys.
Federal Register notice: FDA revokes the emergency use authorizations issued to BioFire Defense for the FilmArray NGDS BT‐E Assay, and Biocartis...
FDA warns Holly Hill, FL-based North American Diagnostics it is illegally manufacturing and distributing adulterated and misbranded Covid-19 test kits...
