FDA accepts for priority review a GSK supplemental BLA to extend the indication of its Arexvy adjuvanted respiratory syncytial virus vaccine to adults...
FDA commissioner Robert Califf and two of his top associates describe how the agency uses its role to help address common chronic diseases.
Bipartisan members of the House introduce legislation to require FDA to produce a final rule to implement animal testing reforms approved at the end o...
FDA grants Orthoson a breakthrough device designation for its Bio-Structural Gel and its use to reduce back pain caused by degenerative disc disease.
FDA publishes a draft guidance with information on how applicants and manufacturers should inform the agency about discontinuance of or interruptions ...
FDA warns Saint-Laurent, Canada-based Les Importations Herbasant about CGMP violations in its work as a contract drug manufacturer.
Three SheppardMullin attorneys say a recent Office of Prescription Drug Promotion untitled letter shows how FDA will continue to monitor DTC ads for a...
FDA warns Chinas Nantong Furuida Packaging Products about a CGMP violation in its manufacturing of over-the-counter drugs.
