Federal Register notice: FDA seeks comments on an information collection extension entitled Postmarket Surveillance of Medical Devices 21 CFR Part 82...
Harvard Medical School researchers call for major changes to dietary supplement listing proposed legislation.
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 withdraws 2 Zydelig lymphoma indications that received accelerated approval because the firm failed to demonstrate a clin...
FDA issues a complete response letter to Verrica for its VP-102 dermatology NDA.
Three Hyman Phelps attorneys question as irresponsible FDAs decision to issue a safety communication about non-invasive prenatal tests without providi...