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FDA clears an Anumana 510(k) for an artificial intelligencebased tool designed to detect early signs of pulmonary hypertension.[ Price : $8.95]
FDA posts a Form 483 that identifies deficiencies in quality system procedures at a manufacturing facility operated by CSL Behring...[ Price : $8.95]
FDAs new draft guidance outlining expectations for how drug manufacturers should respond to Form FDA 483 observations following in...[ Price : $8.95]
FDA commissioner Marty Makary shares his expansive vision for future medical breakthroughs, telling agency staff he hopes to see t...[ Price : $8.95]
FDA says beginning 10/1 it will require drugmakers and other regulated entities to adopt updated international data standards for ...[ Price : $8.95]
FDA grants Context Therapeutics a fast-track designation for its experimental therapy CTIM-76 for treating platinum-resistant ovar...[ Price : $8.95]
HHS is considering reversing a 2023 FDA decision that deemed a group of peptide drugs too risky for use by compounding pharmacies,...[ Price : $8.95]
FDA denies a petition seeking a partial exemption of 510(k) requirements for some specific radiology computer-aided detection and/...