FDA appears to be backing the approval of Novo Nordisks Glucagon-like peptide-1 (GLP-1) diabetes drug semaglutide as it heads for an advisory committe...
FDA clears a Stryker 510(k) for its cementless Mako Total Knee with Triathlon Tritanium.
FDA clears a NuVasive 510(k) for the TLX interbody system for use in spinal fusion surgery.
FDA accepts for review a Bristol-Myers Squibb supplemental BLA for Opdivo (nivolumab) to treat patients with melanoma who are at high risk of disease ...
A Pew Charitable Trust Stateline report examines a push by states to relax off-label communications between the pharmaceutical marketers and physician...
Federal Register notice: FDA seeks comments on an information collection extension for Medical Devices; Humanitarian Use Devices (HUDs) 21 CFR 814. ...
Federal Register notice: FDA sends to OMB an information collection extension request for a guidance on Registration of Human Drug Compounding Outsour...
Federal Register notice: FDA sends to OMB an information collection extension request for a guidance on Fees for Human Drug Compounding Outsourcing Fa...