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.
Regeneron Pharmaceuticals releases favorable Phase 3 data for its RNA-based therapy cemdisiran and says it will seek FDA approval early next year for ...
Eli Lilly plans to seek approval for its investigational obesity pill orforglipron following positive topline results from the Phase 3 ATTAIN-2 trial....
FDA warns North Brunswick, NJ-based LeMaitre Vascular about Quality System Regulation and other violations in its manufacturing of vascular grafts.
FDA grants fast track designation to Allarity Therapeutics investigational ovarian cancer drug stenoparib.
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...
