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...
Chinese medical school researchers who analyzed cancer drug surrogate endpoint approvals in the U.S. and China say China appears to take a stricter ap...
Researchers say some issues need to be resolved if patient-reported outcomes are to be used as a surrogate in heart failure drug and device trials.
