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...
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...
FDA expands the approved use of Amgens cholesterol-lowering drug Repatha (evolocumab) to include adults at increased risk of major adverse cardiovascu...
Argenx says it will seek expanded approval for Vyvgart (efgartigimod alfa-fcab) to include adults with acetylcholine receptor antibody seronegative ge...
CBER suspends Valneva Austrias BLA for Ixchiq (chikungunya vaccine, live) due to serious safety concerns related to the vaccine.
