FDA issues a device safety alert on thermal imaging systems intended to measure human body temperature because improper use could provide inaccurate t...
FDA issues Cue Health an emergency use authorization for its Cue Covid-19 Test for home and over the counter use.
FDA acting commissioner Janet Woodcock tells NPRs All Things Considered that the agency is now free of political pressure and making science- and data...
FDA warns against the use of ivermectin to treat Covid-19, citing safety concerns.
FDA accepts for review an Ocular Therapeutix supplemental NDA for Dextenza (dexamethasone ophthalmic insert) 0.4 mg for treating ocular itching associ...
FDA grants MedAlliance a breakthrough designation for its Selution SLR, a sustained drug-eluting (sirolimus) catheter for treating atherosclerotic les...
Federal Register notice: FDA determines that Eisais Belviq and Belviq XR (lorcaserin hydrochloride) tablets were withdrawn from sale for reasons of sa...
Federal Register notice: FDA seeks industry organizations interested in participating in the selection of a nonvoting industry representative to serve...