FDA clears an Inflammatix 510(k) for its TriVerity Test System, which it describes as a first-in-class molecular test for patients with suspected acut...
FDA warns San Antonio, TX-based Incell Corp. about CGMP and other issues in its work as a contract manufacturer of a product derived from amniotic flu...
FDA issues an amended Warning Letter to Sanofis Genzyme unit in Framingham, MA, about CGMP deviations in its manufacturing of active pharmaceutical in...
FDA approves a Johnson & Johnson supplemental NDA for Spravato (esketamine) nasal spray for monotherapy use in treating major depressive disorder in a...
FDA publishes a guidance on a bioanalytical method to validate biomarkers in drug and biological product applications.
FDA releases the form FDA-483 with seven observations from an inspection at the Windsor, CT-based SCA Pharmaceuticals outsourcing facility.
President Donald Trump orders all government departments and agencies like FDA to end work-from-home arrangements and head back to the office as soon ...
FDA accepts for priority review a Replimune Group BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced mel...
