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...
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.
