Advanced Medical Technology Association urges FDA to narrow and clarify a draft guidance on quality management system information, warning that the cu...
Moderna and Merck report updated five-year follow-up data that show their personalized mRNA cancer vaccine candidate, intismeran autogene, significant...
Novo Nordisk submits to FDA additional studies and analyses it says support its petition asking the agency to act against compounded forms of its sema...
FDA warns Temecula, CA-based Prodrome Sciences USA about violations in its conduct of a clinical trial without submitting an IND.
FDA posts a draft guidance outlining how drug developers can use minimal residual disease and complete response as primary endpoints in multiple myelo...
FDA asks Capricor Therapeutics for a full clinical study report from the companys Phase 3 HOPE-3 trial as part of its ongoing BLA review for Deramioce...
FDA publishes for review and comment the International Council for Harmonization M4Q(R2) guidance establishing the location and structure of quality i...
FDA warns Integrity Partners St. Louis, MO-based Chemisphere drug manufacturing facility about CGMP issues in its production of finished drugs as a co...
