FDA awards Precision NeuroMed an orphan drug designation for IL13-PE38QQR (cintredekin besudotox), an investigational therapy targeting glioblastoma m...
FDA says it is monitoring reports of contaminated childrens cough and cold medicines manufactured in India but confirmed that the affected products di...
A Gallup Poll shows that Americans ratings of FDA and many other federal agencies have dropped in the last year to at or near their lowest point.
FDA grants Adcendo a fast track designation for ADCE-D01, an investigational antibody-drug conjugate being developed for treating soft tissue sarcoma.
A new analysis from investment firm Jefferies finds that nearly three-quarters of drug candidates that received an FDA breakthrough therapy designatio...
FDA clears a Methinks AI 510(k) for its Methinks CTA Stroke, an artificial intelligencebased software tool that detects suspected large vessel occlusi...
FDA releases a table of drug development contexts that could be used to help reduce animal testing.
FDA releases the form FDA-483 with eight observations from an inspection at the Aurobindo Pharma drug manufacturing facility in Bachupally, Hyderabad,...
