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...
Two Brookings Institution fellows suggest three steps to address the shortage of generic sterile injectable drugs.
FDA grants full approval to Amgens previously accelerated-approved BLA for Blincyto (blinatumomab) for treating certain adults and pediatric patients ...
