FDA approves Kedrion Biopharma and Kmada Ltd.s KedRab [rabies immune globulin (human)] for passive, transient post-exposure prophylaxis of rabies infe...
Federal Register notice: FDA makes available a guidance for industry #237 entitled Oncology Drugs for Companion Animals.
FDA approves a Teligent ANDA for clobetasol propionate cream USP, 0.05%, emollient.
US Bioservices agrees to pay $13.4 million to resolve claims against it for being part of a kickback scheme involving Novartis Exjade.
FDA researchers discuss difficulties in using post-marketing studies to determine how successful an opioids abuse-deterrent formulation is.
Genmab and Janssen plan to meet with FDA and other global regulators following positive Phase 3 data being reported from the ALCYONE study of daratumu...
Two attorneys are continuing their effort to persuade FDA not to declassify electroconvulsive therapy devices and make them more readily available.
FDA tells Congress that in FY 2016 it approved 13 PMAs for use in a pediatric population or subpopulation.