Federal Register notice: FDA extends the comment period on its proposed rule entitled Labeling Requirements for Approved or Conditionally Approved New...
Based on disappointing Phase 3 trial data, Otsuka Pharmaceutical terminates its development of the novel compound AVP-786 as a potential treatment for...
FDA asks an advisory panel to vote on the safety and effectiveness of the Guardant Shield colorectal screening test for use with patients at average r...
Federal Register notice: FDA requests that any industry organizations interested in participating in the selection of nonvoting industry representativ...
AdvaMed makes five suggestions to help FDA improve revised Accreditation Scheme for Conformity Assessment guidances.
FDA medical reviewers share with the Endocrinologic and Metabolic Drugs Advisory Committee their concerns about an increased risk of hypoglycemia in T...
FDA Oncology Drugs Division director Harpreet Singh leaves the agency to join Precision for Medicine as chief medical officer.
Public Citizen sues FDA to force it to act on a six-year-old petition seeking labeling changes for SSRIs and SNRIs to highlight the risk of sexual sid...
