Fresenius Kabi USA recalls its Ivenix Infusion Systems pump software due to a necessary software update.
FDA warns Soulaire Corp. that it is marketing an external counterpulsation system for unapproved uses, adulterating and misbranding the unit.
FDA warns the Telangana, India-based Natco Pharma manufacturing facility about CGMP violations in its production of finished drugs.
CDER establishes the Center for Clinical Trial Innovation to support innovative approaches to clinical trials that are designed to improve the quality...
A federal court sentences former Decision Diagnostics CEO Keith Berman to seven years in prison for a securities fraud scheme involving a Covid-detect...
FDA issues a safety alert on unsafe counterfeit versions of AbbVies Botox (botulinum toxin) have been found in multiple states and administered to con...
FDA approves an Xstim PMA for the Xstim Spine Fusion Stimulator for bone growth stimulation.
FDA adds CBER to its partnership with the Lupus Accelerating Breakthroughs Consortium to better focus on engineered cell therapies.
