[ Price : $8.95]
A new Form FDA-483 cites significant GMP issues at the plant that makes Regenerons Eylea HD (aflibercept), delaying review of two ...[ Price : $8.95]
FDA clears a Signos 510(k) for what the company says is the first over-the-counter glucose monitoring system designed specifically...[ Price : $8.95]
FDA is now publishing drug safety data on a daily basis, a shift the agency says will give the public faster access to information...[ Price : $8.95]
FDA publishes a guidance with recommendations for 510(k) animal studies for dental bone grafting material devices.[ Price : $8.95]
FDA publishes a draft guidance with recommendations for approaches to assessing overall survival in oncology clinical trials.[ Price : $8.95]
FDA accepts for review a Stealth BioTherapeutics NDA resubmission for elamipretide for treating Barth syndrome, with the agency ag...[ Price : $8.95]
Nicox plans an NDA early next year after new data from its DENALI Phase 3 study of glaucoma therapy NCX 470 showed promising resul...[ Price : $8.95]
Researchers call for greater transparency of artificial intelligence/machine learning training and validation datasets in devices ...