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FDA publishes a draft guidance with recommendations for approaches to assessing overall survival in oncology clinical trials.[ Price : $8.95]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 ...[ Price : $8.95]
FDA approves an Ionis Pharmaceuticals NDA for Dawnzera (donidalorsen) as the first RNA-targeted prophylactic treatment for heredit...[ Price : $8.95]
AbbVie reports that its JAK inhibitor Rinvoq (upadacitinib) met primary and secondary endpoints in a pivotal Phase 3 study testing...[ Price : $8.95]
An in-depth ProPublica report details the effects of massive staffing cuts at FDA and other HHS agencies that experts say threaten...[ Price : $8.95]
14 states join a petition submitted by four other states calling on FDA to eliminate the mifepristone REMS requirements in their s...