Amarin files a supplemental NDA seeking an expanded indication for Vascepa (icosapent ethyl) capsules based on data from the REDUCE-IT cardiovascular ...
Bloomberg News says FDA is working on changes to drug manufacturing regulations to reduce problems with contaminated active pharmaceutical ingredients...
DLA Piper attorneys say a 2nd Circuit Court of Appeals decision in a case involving Bristol-Myers Squibb and Pfizers Eliquis strengthens preemption la...
Federal Register proposed rule: FDA proposes to update the mammography regulations that were issued under the Mammography Quality Standards Act of 199...
Federal Register notice: FDA has announced the renewal of the Cellular, Tissue and Gene Therapies Advisory Committee for an additional two years.
Federal Register notice: FDA makes available a final guidance entitled Pediatric Information Incorporated Into Human Prescription Drug and Biological ...
FDA Commissioner Scott Gottlieb says that device summary reporting about adverse events that have been hidden to the public and researchers will be ma...
FDA approves UCBs Cimiza for treating adults with non-radiographic axial spondyloarthritis, with objective signs of inflammation.