FDA releases the form FDA-483 with three observations issued following an inspection at the Hikma outsourcing facility in Cherry Hill, NJ.
The Duke-Margolis Institute for Health Policy issues a summary with five broad themes from a meeting co-sponsored with FDA on increasing clinical tria...
Pfizer selects its preferred once-daily modified-release formulation for danuglipron, an oral glucagon-like peptide-1 receptor agonist it is developin...
FDA issues Novo Nordisk a complete response letter on its BLA for once-weekly basal insulin icodec, indicated for treating diabetes mellitus.
FDA publishes a guidance recommending principles for use in pivotal clinical studies to demonstrate the safety and effectiveness of medical devices tr...
Kazia Therapeutics says it will meet with FDA about a potential accelerated approval pathway for its glioblastoma drug paxalisib following positive ov...
Federal Register notice: FDA announces an 8/6 public workshop entitled Artificial Intelligence (AI) in Drug & Biological Product Development.
Federal Register: FDA schedules an 8/2 advisory committee meeting to discuss a Zevra Denmark A/S NDA for arimoclomol, indicated for treating Niemann-P...
