FDA releases the Form 483 behind a 3/5 Warning Letter to Novo Nordisk that cited serious violations of postmarketing adverse drug experience reporting...
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...
FDA approves an expanded use of GSKs Wellcovorin (leucovorin calcium) tablets for treating cerebral folate deficiency in adult and pediatric patients....
FDA warns Westphalia, Germany-based Simtra BioPharma Solutions about CGMP violations in its manufacturing of finished drugs.
FDA warns Novo Nordisk in Plainsboro, NJ, about its failure to meet postmarketing adverse drug experience reporting requirements.
FDA warns Frances Fareva about CGMP violations in the production of finished drugs at its Morton Grove, IL, manufacturing facility.
