Recent FDA layoffs raise concerns across the drug and biologic industries as experts warn that diminished inspection capacity could slow drug approval...
FDA warns Downey, CA-based Naturista Store that it is marketing an unapproved, misbranded drug as a dietary supplement that contains undeclared active...
FDA warns Clarence, NY-based PMS4PMS that it is illegally marketing a misbranded over-the-counter menstrual cream that is manufactured with CGMP viola...
FDA clears a Phase 1 human trial of an eGenesis porcine liver for use with an OrganOx system for perfusion of intensive care patients with acute-on-ch...
Sanofi says data from a Phase 2 study of amlitelimab misses its endpoint in adults with moderate-to-severe asthma, while promising data were seen in h...
Mural Oncology discontinues all clinical development of its lead drug candidate, nemvaleukin alfa based on disappointing results from two key trials i...
FDA grants Click Therapeutics a de novo marketing authorization for its prescription digital therapeutic, CT-132, a prescription digital therapeutic f...
FDA clears a TytoCare 510(k) for its Tyto Insights for Rhonchi Detection, an artificial intelligence-based device for detecting all three major abnorm...
