FDA tells the DC District Court that a recent Novartis lawsuit that seeks a preliminary injunction to reverse the agencys approval of MSN Laboratories...
FDA warns Melville, NY-based Velocity Pharma that it has received and distributed adulterated eye drop products produced for it by a contract manufact...
FDA warns Chinas Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. about CGMP violations in its production of finished drugs.
Federal Register notice: FDA announces a 9/6 public workshop entitled Enhancing Diversity in Therapeutics Development for Pediatric Patients to discus...
The Justice Department says a Virginia man who pleaded guilty to distributing misbranded drugs via the Internet has been sentenced to two years in fed...
Foundation Medicine petitions FDA to reclassify all next-generation sequencing oncology panel devices used for somatic or germline variant detection t...
FDA accepts for review an Exelixis supplemental NDA for Cabometyx (cabozantinib) and its use for treating certain adults with pancreatic and extra-pan...
CDRH publishes a discussion paper to seek public feedback on the issue of health equity in the context of medical devices.
