FDA publishes a draft guidance with recommendations for approaches to assessing overall survival in oncology clinical trials.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...
AbbVie reports that its JAK inhibitor Rinvoq (upadacitinib) met primary and secondary endpoints in a pivotal Phase 3 study testing the drug in patient...
An in-depth ProPublica report details the effects of massive staffing cuts at FDA and other HHS agencies that experts say threaten to set back public ...
14 states join a petition submitted by four other states calling on FDA to eliminate the mifepristone REMS requirements in their states or exercise di...
