An FDA update says contrary to an earlier alert, all new neonatal incubators currently supplied in the U.S. do not show concerning levels of airborne ...
FDA grants AstraZeneca traditional approval for Calquence (acalabrutinib) with bendamustine and rituximab for adults with previously untreated mantle ...
CDRHs annual report says it granted marketing authorization to 120 novel devices in 2024, which was four less than the previous years record-setting 1...
Federal Register notice: FDA seeks public comments on the use of cannabis-derived products (CDPs) in animals.
FDA commissioner Robert Califf and three former commissioners offer their perspectives on the ways the incoming administration can succeed at FDA.
Boehringer Ingelheim reports disappointing data from its CONNEX clinical trial program evaluating iclepertin in cognitive impairment in adults with sc...
Medline Industries recalls its Medline Fluid Delivery Set with Drip Chamber because the devices were incorrectly assembled.
Citing potentially lethal risk, an FDA Early Alert says Fresenius Kabi is recommending updates to some software for its Ivenix Infusion System.
