FDA warns Chinas Jiangsu Kerbio Technology Group Co. about its violations of good laboratory practice regulations for nonclinical studies.
FDA grants Santersus a breakthrough device designation for its NucleoCapture blood purification system for patients with severe, treatment-resistant s...
Inovio Pharmaceuticals begins a rolling BLA submission for INO-3107, an experimental DNA medicine for recurrent respiratory papillomatosis.
CBER suspends Valneva Austrias BLA for Ixchiq (chikungunya vaccine, live) due to serious safety concerns related to the vaccine.
An FDA clinical trial finds that daily use of cannabidiol at levels typically used by consumers can cause elevated liver enzymes in otherwise healthy ...
FDA accepts for priority review a Gamida Cell supplemental BLA for omidubicel and its use in severe aplastic anemia.
FDA grants Quest Diagnostics a breakthrough device designation for its Haystack MRD test, a liquid biopsy designed to detect minimal residual disease ...
FDA alerts health care providers and facilities about the safe use of hyperbaric oxygen therapy devices following reports of serious injuries and deat...
