NJ attorney general Gurbir S. Grewal announces a $5 million settlement with Insys Therapeutics founder John N. Kapoor to resolve allegations that he u...
The Medical Device Innovation Consortium says it will receive comments for the next month on its External Evidence Methods Framework.
FDA issues a guidance to give manufacturers of licensed and investigational cellular and gene therapy products risk-based recommendations to minimize ...
FDA accepts for priority review a Genentech supplemental NDA for Esbriet (pirfenidone) for treating unclassifiable interstitial lung disease.
Federal Register notice: FDA withdraws a draft guidance entitled Applications for Premarket Review of New Tobacco Products.
FDA clears a Canon Medical Systems 510(k) for the Aquilion Exceed LB CT system.
PhRMA asks for changes to an FDA draft guidance on biosimilarity and interchangeability.
FDA approves ViiVs Cabenuva and Vocabria to treat HIV-1 infection in some adults.