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 ...
FDA sends Nymox Pharmaceutical a Refusal to File letter for its NDA for fexapotide triflutate for treating benign prostatic hyperplasia, requesting lo...