FDA warns Novo Nordisk in Plainsboro, NJ, about its failure to meet postmarketing adverse drug experience reporting requirements.
Five Sidley attorneys recommend ways in which drug companies can analyze their direct-to-consumer promotions to see if they are likely to run afoul of...
FDA warns Frances Fareva about CGMP violations in the production of finished drugs at its Morton Grove, IL, manufacturing facility.
The Institute for Safe Medicines calls on FDA, the Federal Trade Commission, and the Department of Justice to take enforcement action against Hims & H...
FDA approves an expanded use of GSKs Wellcovorin (leucovorin calcium) tablets for treating cerebral folate deficiency in adult and pediatric patients....
FDA cites a U.K.-based clinical research center for failing to promptly report adverse events and for potential falsification of study records during ...
Vertex Pharmaceuticals says an interim analysis of its Phase 3 RAINIER trial showed its experimental therapy povetacicept significantly reduced protei...
FDA accepts for review a Capricor Therapeutics BLA resubmission for its experimental cell therapy deramiocel, intended to treat heart complications in...
