Cumberland Pharmaceuticals asks FDA to ensure that labeling for generic Acetadote products includes information from the innovator labeling about a tw...
FDA joins the United States Pharmacopeia and the Association for Accessible Medicines next month for a public workshop focused on how compendial stand...
Orrick attorneys say discussions at an FDA Digital Health Advisory Committee meeting indicate the agency intends to adopt oversight of generative arti...
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...
