Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Siga Technologies Tpoxx (tecovirimat monohydrat...
Federal Register notice: FDA determines that Fougera Pharmaceuticals Cutivate (fluticasone propionate) ointment, 0.005%, was not withdrawn from sale f...
Federal Register notice: FDA determines that Novartis Serentil (mesoridazine besylate) tablets 10 mg, 25 mg, 50 mg, and 100 mg were not withdrawn from...
FDA calls attention to the risk of infections associated with reprocessed urological endoscopes.
Johnson & Johnson says it is sending quality and compliance experts to its contract manufacturer Emergent Biosolutions after 15 million doses of its C...
A GCN report says FDA is relying on the Abbyy digital intelligence platform to analyze and summarize drug safety reports.
FDA grants Abbott an Emergency Use Authorization for over-the-counter, non-prescription, asymptomatic use of its BinaxNow Covid-19 Ag Self Test for de...
FDA says Apotex is recalling three lots of Guanfacine extended-release tablets after finding contamination in one lot.