Federal Register notice: FDA permanently debars Daylen Diaz from providing services in any capacity to a person that has an approved or pending drug p...
The Physicians Committee for Responsible Medicine asks FDA to require a notice on all glucagon-like peptide-1 receptor agonists that a plant-based die...
FDA warns Highland, IL-based Chicago Cornea Consultants about violations in its conduct of two clinical studies with investigational drugs.
FDA accepts for priority review a bluebird bio BLA for lovotibeglogene autotemcel (lovo-cel), a gene therapy for certain patients with sickle cell dis...
Pieris Pharmaceuticals says its partner AstraZeneca is discontinuing a Phase 2a study of the asthma drug elarekibep.
An FDA complete response letter for Aldeyras ADX-2191 cites a lack of substantial evidence of effectiveness due to a lack of clinical trials.
FDA grants Anumana a breakthrough device designation for its ECG-AI algorithm for detecting cardiac amyloidosis.
FDA commissioner Robert Califf says the agency needs to get in front of regulating large language models using ChatGPT that could be used in medical d...
