Atara Biotherapeutics says it has reached an agreement with FDA on the steps needed to lift agency clinical holds on its Ebvallo and ATA3219.
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 ...
