FDA approves Promegas OncoMate MSI Dx Analysis System as a companion diagnostic for identifying endometrial carcinoma patients who may benefit from tr...
FDA warns New Zealands Miers Laboratories about repeat CGMP violations in its manufacturing of finished drugs.
Neurocrine Biosciences reports that its Phase 2 study of NBI-1070770, an investigational NMDA receptor modulator for major depressive disorder, failed...
Alston & Bird attorneys urge medical device companies to move quickly to prepare to implement FDAs new Quality Management System Regulation next Febru...
enGene says Phase 2 data showed that its gene therapy detalimogene voraplasmid produced a 62% complete response rate at six months in patients with hi...
FDA Matters president Steven Grossman says FDAs top officials can improve agency morale by increasing the trust felt by lower-level staff that they ar...
FDA warns Chinas Taizhou Kangping Medical Science and Technology Co. about CGMP violations in its manufacturing of over-the-counter drugs.
FDA names 26-year FDA veteran Richard Pazdur as the new CDER director, replacing George Tidmarsh after he recently stepped down amid an internal ethic...
