An FDA advisory committee votes Wednesday to recommend approval of Grail's Galleri multi-cancer early detection blood test, voting unanimously, 10-0, ...
Four major stakeholders give numerous suggestions for significantly changing or improving an FDA draft guidance that revises the agencys approach to d...
An FDA online post explains the benefits of CDER scientists work in proteomics-based biomarker discovery.
FDA accepts a letter of intent for a wearable sensor-based digital outcome measure designed to assess foot drop severity and gait impairment in patien...
Former FDA head Scott Gottlieb appears on CNBC to throw his support behind commissioner-nominee Heidi Overton on the eve of her Senate confirmation he...
A citizen petition seeks a safety investigation and potential recall of Intuitive Surgical's da Vinci Permanent Cautery Spatula, citing reports of mec...
FDA Matters blog author Steven Grossman urges the Senate HELP Committee to examine how FDA commissioner-nominee Heidi Overton intends to make regulato...
FDA recommends that Compass Therapeutics conduct an additional clinical trial demonstrating an overall survival benefit before submitting a BLA for to...
