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...
FDA grants Avenzo Therapeutics a fast track designation for AVZO-1418, the companys investigational EGFR/HER3 bispecific antibody-drug conjugate being...
