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 grants Keros Therapeutics an orphan drug designation for its investigational therapy KER-065 and its use in treating Duchenne muscular dystrophy.
FDA publishes a guidance with recommendations for 510(k) animal studies for dental bone grafting material devices.
FDA publishes a draft guidance with recommendations for approaches to assessing overall survival in oncology clinical trials.
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...
