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.
After being forced to resign in April, former CBER director Peter Marks accepts a job at Lilly Research Laboratories overseeing molecule discovery and...
FDA lifts a clinical hold on Neurizon Therapeutics on its lead experimental treatment for amyotrophic lateral sclerosis.
FDA accepts for priority review an Orca Bio BLA for Orca-T, an investigational allogeneic T-cell immunotherapy for patients with certain blood cancers...
FDA grants IceCure Medicals de novo marketing authorization for the ProSense cryoablation system for treating early-stage, low-risk breast cancer in w...
FDA issues Dr. Reddy's Laboratories a five-item Form FDA-483 after inspecting the firms drug substance and drug product manufacturing facility last mo...
