A Sidley law briefing examines HHSs unprecedented overreach during the Trump Administration, which has drawn increased interest in making FDA an indep...
FDA approves an Exelixis NDA for Cabometyx (cabozantinib) in combination with Bristol Myers-Squibbs Opdivo (nivolumab) for treating patients with adva...
FDA gives the green light to Ultragenyx Pharmaceutical to begin a seamless single-protocol Phase 1/2/3 study of UX701, an investigational AAV9 gene th...
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.