FDA grants Theriva Biologics a fast-track designation for its lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel for tr...
Pharmaceutical Research and Manufacturers of America asks FDA to address four issues relating to implementation of the FDA Reauthorization Act.
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...
