A new Form FDA-483 cites significant GMP issues at the plant that makes Regenerons Eylea HD (aflibercept), delaying review of two related regulatory s...
FDA clears a Signos 510(k) for what the company says is the first over-the-counter glucose monitoring system designed specifically for weight manageme...
FDA is now publishing drug safety data on a daily basis, a shift the agency says will give the public faster access to information about adverse event...
FDA accepts for review a Stealth BioTherapeutics NDA resubmission for elamipretide for treating Barth syndrome, with the agency agreeing to expedite i...
Nicox plans an NDA early next year after new data from its DENALI Phase 3 study of glaucoma therapy NCX 470 showed promising results compared to stand...
Researchers call for greater transparency of artificial intelligence/machine learning training and validation datasets in devices intended to manage A...
FDA approves an Ionis Pharmaceuticals NDA for Dawnzera (donidalorsen) as the first RNA-targeted prophylactic treatment for hereditary angioedema in pa...
AbbVie reports that its JAK inhibitor Rinvoq (upadacitinib) met primary and secondary endpoints in a pivotal Phase 3 study testing the drug in patient...
