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...
FDA announces a 10/23 public workshop to discuss the regulatory status of, and potential alternatives to, patch tests used in diagnosing allergic cont...
Nucleus RadioPharma appoints former FDA commissioner Stephen Hahn (Trump Administration 2019-2021) as its chief executive officer.
