FDA accepts for review a Bristol Myers Squibb BLA for a subcutaneous formulation of Opdivo (nivolumab) across all previously approved adult solid tumo...
FDA publishes a final guidance to clarify the distinctions between medical device remanufacturing and servicing.
A BMJ investigation looks at the relationship between several FDA commissioners and the companies the agency regulates.
FDA says Exocel Bio in San Diego is marketing unapproved exosome products.
CDER director Patrizia Cavazzoni provides an update on the reorganization of FDAs Office of Regulatory Affairs (ORA) regarding inspection activities, ...
FDA grants Avidity Biosciences a breakthrough therapy designation for delpacibart etedesiran and its use in treating myotonic dystrophy Type 1.
FDA reminds healthcare providers and facilities about the agencys continuing safety and quality concerns with some Getinge/Maquet cardiovascular medic...
FDA says it has worked with EPA and USDA to develop a biotechnology regulatory reform program as required by a presidential Executive Order.
