CDER director Patrizia Cavazzoni outlines budget priorities for FY 2023, including a priority to improve drug postmarket surveillance and oversight of...
FDA approves a GE Healthcare PMA for its End-tidal (Et) Control software for general anesthesia delivery on its Aisys CS2Anesthesia Delivery System.
FDA warns Monterey, CA-based NDAL Mfg. that it is manufacturing unapproved new drugs with CGMP violations.
AstraZeneca and Janssen comment on an FDA draft guidance on immunogenicity information in drug product labeling.
FDA says the availability of duodenoscopes that are fully disposable or have disposable components should lead to hospitals and endoscopy facilities m...
Seven senators ask the HHS Inspector General to look into McKinsey & Company's conflicts of interest while working with FDA and the agencys contractin...
Immunome plans a Phase 1b trial after FDA lifts a clinical hold on its antibody cocktail (IMM-BCP-01) for treating Covid-19.
FDA says an agency advisory committee will discuss 4/6 what the optimal strain composition might be for Covid-19 vaccines/boosters to address emerging...