Federal Register notice: FDA makes available a final guidance entitled Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Progr...
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.
