FDA releases more details on a CDER and ORA concept of operations agreement to integrate facility evaluations and inspections for human drugs.
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.