FDA approves Amgens Lumakras (sotorasib) for use with its Vectibix (panitumumab) for adult patients with KRAS G12C-mutated metastatic colorectal cance...
CDER posts its latest guidance agenda that shows it is committing to issuing 11 drug quality guidance documents in 2025.
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.
