FDA grants fast track designation for Elevation Oncologys seribantumab for the tumor-agnostic treatment of advanced solid tumors that harbor NRG1 gene...
FDA clears an inHeart 510(k) for its inHeart Models software suite that enables 3D visualization and analysis of anatomical structures for pre-procedu...
FDA approves a Servier supplemental NDA for Tibsovo (ivosidenib tablets) in combination with azacitidine for treating newly diagnosed IDH1-mutated acu...
Federal Register notice: FDA releases a final guidance entitled Importation of Prescription Drugs Final Rule Questions and Answers.
FDA accepts for review a Phathom Pharmaceuticals NDA for vonoprazan as a treatment for adults in healing all grades of erosive esophagitis and relief ...
FDA publishes a question-and-answer guidance for small entities on the provisions in the 2020 final rule on prescription drug importation.
Federal Register notice: FDA extends the comment period on a proposed rule on national standards for licensure for wholesale drug distributors that pu...
Federal Register notice: FDA revokes the Emergency Use Authorization (EUA) issued to Clinical Research Sequencing Platform LLC at the Broad Institute ...