Novo Nordisk files a supplemental NDA seeking approval for a higher-dose version of weight-loss drug Wegovy (semaglutide).
A law journal article, discussed in Regulatory Review, proposes a framework courts could use to consider state challenges to federal preemption of dru...
The Department of Justice says a Massachusetts federal judge sentenced three former Magellan Diagnostics executives for hiding a malfunction in the co...
FDA warns Chinas Hong Qiangxing Shenzhen Electronics about Quality System violations in its production of several medical devices.
FDA warns Baton Rouge, LA-based Owen Biosciences about CGMP violations in its production of finished drugs as a contract manufacturing facility.
FDA approves Novartis Itvisma (onasemnogene abeparvovec-brve), a new formulation of a gene therapy for a broader age of spinal muscular atrophy patien...
FDA issues a draft guidance with recommendations to help master file holders determine to which Center to submit cross-Center master files.
National Center for Health Research president Diana Zuckerman defends FDA advisory committees, saying they do a more thorough job of evaluating produc...
