AstraZeneca says its investigational drug baxdrostat met the primary endpoint in the Phase 3 Bax24 trial in patients with resistant hypertension.
Thirteen Republican House members call on HHS to lay off the CDER director, Office of Generic Drugs director, and others who were behind the approval ...
FDA clears restart of a pivotal clinical trial evaluating the NobleStitch EL system, a device-free, suture-mediated method for closing a patent forame...
FDA approves a Boehringer Ingelheim NDA for Jascayd (nerandomilast) tablets for treating idiopathic pulmonary fibrosis.
A Hyman, Phelps & McNamara statistical analysis of FDA Warning Letters published by FDLI shows that nearly three-quarters of Warning Letters are issue...
FDA warns West Palm Beach, FL-based Technological Medical Advancement about Quality System violations in its production of two unapproved laser system...
FDA warns Santa Fe Springs, CA-based Creative Essences about CGMP violations in its production of misbranded unapproved drugs.
FDA input offers Lexeo Therapeutics a potential accelerated approval pathway for its investigational gene therapy LX2006.
