FDA extends by three months its review of an Axogen BLA for Avance Nerve Graft after the agency determined that information submitted by the company i...
FDA warns Westborough, MA-based Miach Orthopaedics about eight Quality System and three Medical Device Reporting violations in its production of the B...
The Biotechnology Innovation Organization says its congressional lobbying priorities for September are reauthorization of the FDA pediatric priority r...
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 ...
