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Federal Register notice: FDA determines that Eisais Belviq and Belviq XR (lorcaserin hydrochloride) tablets were withdrawn from sale for reasons of sa...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...
Morrison & Foerster attorneys say its not yet known what FDA will want from sponsors in its regulation of artificial intelligence/machine learning in ...
The New Jersey Superior Court says county courts should allow jurors to consider FDA 510(k) clearance in two pelvic mesh medical device cases.
Federal Register notice: FDA announces that a collection of information entitled Obtaining Information to Understand and Challenges and Opportunities ...