Former FDA commissioner Scott Gottlieb raises significant questions about the current administrations handling of vaccines and vaccine innovation in w...
FDA says Sandoz has recalled one lot of Cefazolin for injection following a customer complaint that vials of another drug were included in a Cefazolin...
FDA clears Philips SmartSpeed Precise AI-enhanced software for MRI systems.
FDA publishes a draft guidance to assist sponsors in developing drugs to treat myelodysplastic syndromes.
Moderna says its mRNA-1010 investigational seasonal flu vaccine achieved very positive results in a Phase 3 efficacy trial.
FDA warns Hialeah, FL-based physician Peter Michael about failing to follow the investigation plan in two clinical studies.
FDA gives accelerated approval to Regenerons Lynozyfic for some multiple myelomas.
FDA warns Hoffman Estates, IL-based InVia Fertility Specialists about multiple violations of regulations governing human cells, tissues, and cellular ...