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.
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 is now publishing drug safety data on a daily basis, a shift the agency says will give the public faster access to information about adverse event...
Vanda Pharmaceuticals urges FDA commissioner Marty Makary to reconsider a recent agency decision upholding approvals of two generic versions of Hetlio...
AdvaMed and other device stakeholders urge the Centers for Medicare & Medicaid Services to overhaul how it covers new device technologies, warning tha...
