FDA warns Denver, CO-based Hygienic Labs that it has not responded to multiple requests for records and information so the agency can assess the quali...
Bristol Myers Squibb says it will seek approval for a subcutaneous formulation of its Opdivo (nivolumab) for use in patients with advanced or metastat...
FDA posts a revised guidance entitled Development and Licensure of Vaccines to Prevent Covid-19.
Nine FDAers discuss the agencys use of real-world data and real-world evidence, and the confusion that exists on those terms and how they are used in ...
FDA publishes a guidance on CBERs voluntary consensus standards recognition program for regenerative therapy products.
FDA publishes a guidance on considerations about a drugs benefits and risks that the agency applies to certain premarket and postmarket regulatory dec...
FDA grants SeaStar Medical Holding a breakthrough device designation for its cell-directed Selective Cytopheretic Device for use in intensive care uni...
Hamilton Medical recalls its Hamilton-C1, T1, MR-1 ventilators because the capacitators may leak electrolyte fluid onto the ventilators control board....
