FDA posts laboratory results showing N- Nitrosodimethylamine levels in some metformin products.
A new Government Accountability Office report on FDAs priority review voucher program finds that they have had little or no effect on drug development...
FDA and FTC agree to crack down on anti-competitive practices, such as making false or misleading statements comparing biological reference products a...
FDA clears a Qynapse 510(k) for its QyScore software that analyzes brain MRI markers that occur early in diseases such as Alzheimers disease, Parkinso...
Boston Scientific issues an urgent field safety notice about installing a firmware update for its Maestro 4000 Cardiac Ablation System to remedy an un...
GW Pharmaceuticals submits a supplemental NDA for Epidiolex (cannabidiol) oral solution for an expanded use to include seizures associated with Tubero...
A DC federal judge sides with FDA in a Vanda Pharmaceuticals lawsuit that sought to remove a partial clinical hold the agency imposed prohibiting Vand...