Speaking at the BIO 2026 convention, former FDAers criticize the informal way in which agency policy was made and announced under former commissioner ...
Sen. Tom Cotton (R-AR) introduces a bill that would require FDA to review and potentially recall Chinese-manufactured networked medical devices deemed...
CeleCor Therapeutics says it has submitted an NDA for Disaggpro (zalunfiban), an investigational treatment for ST-segment elevation myocardial infarct...
The FY2025 FDA Report on the State of Pharmaceutical Quality shows increased quality assurance inspections over FY 2024.
A newly published commentary in the journal Stem Cell Research & Therapy says FDAs efforts to reduce reliance on animal testing is driving a fundament...
Two stakeholders ask for greater specificity in an FDA draft guidance on establishing impurity specifications for antibiotics.
Three stakeholders comment on an FDA request for information on AI-enabled optimization of early-stage clinical trials.
Speaking at a BIO International Convention FDA Town Hall, several agency executives cite increases in hiring and decreases in attrition as signs of an...
