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.
FDA approves Sanofis Sarclisa (isatuximab) for combination use with carfilzomib and dexamethasone in treating adult patients with relapsed or refracto...
Federal Register notice: FDA amends its medical device regulations to make an editorial nonsubstantive change and replace a reference to an obsolete o...
Federal Register notice: FDA announces a 5/27 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss a Provention Bio BLA for eplizu...