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...
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FDA publishes a draft guidance with recommendations for approaches to assessing overall survival in oncology clinical trials.
