FDA places a clinical hold on Bluebird Bios Lenti-D (elivaldogene autotemcel) after the company reported a suspected unexpected serious adverse reacti...
Federal Register notice: FDA seeks consumer organizations interested in participating in the selection of voting and nonvoting consumer representative...
The Federal Circuit Court of Appeals says promotional materials developed by Teva were enough to induce infringement of a GSK carvedilol patent despit...
FDA warns Captains Cloth it is marketing unapproved, adulterated, and misbranded KN95 face masks.
Federal Register notice: FDA announces a 10/6 Patient Engagement Advisory Committee meeting that will discuss and make recommendations on medical devi...
An FDA complete response letter asks FibroGen to conduct additional roxadustat clinical studies before resubmitting its NDA.
FDA warns Vivera Pharmaceuticals it is marketing unapproved, adulterated, and misbranded Covid-19 tests.
SterRx recalls three lots of sodium bicarbonate in 5% dextrose injection 150mEq per 1,000 mL due to waterborne microbial contamination.