CBER director Vinay Prasad orchestrates leadership changes at the Center, appointing several new acting deputy directors and reassigning key staff.
The D.C. federal court says FDA correctly approved labeling for MSNs generic form of Novartis Entresto.
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 warns Lutz, FL-based New Life Medical Services that it is illegally marketing unapproved human cells, tissues, and cellular and tissue-based produ...
