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.
Vyaire Medical recalls (Class 1) its Twin Tube sample lines, which are used on the Vyntus CPX Cardiopulmonary Exercise Test, due to the potential for ...
Federal Register notice: FDA makes available a draft revised guidance entitled Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human...
FDA approves a CorTec IDE to allow the University of Washington School of Medicine to conduct a study involving the closed-loop Brain Interchange Impl...
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...
