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Three Democratic senators led by presidential hopeful Elizabeth Warren raise concerns about CDRHs regulation of digital health dev...[ Price : $8.95]
Members of the FDA Oncologic Drugs Advisory Committee vote unanimously to recommend approval of a Celltrion biosimilar to Biogens ...[ Price : $8.95]
FDA lifts a clinical hold against a CRISPR Therapeutics and Vertex Pharmaceuticals IND for CTX001 for treating sickle cell disease...[ Price : $8.95]
Biotechnology Innovation Organization submits comments to FDA on its draft guidance Opioid Use Disorder (OUD): Endpoints for Demon...[ Price : $8.95]
FDA clears a Vapotherm 510(k) for its latest version of its Precision Flow Hi-VNI system, which includes a new product category an...[ Price : $8.95]
Federal Register notice: FDA requests comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impa...[ Price : $8.95]
A federal government brief tells the Supreme Court that the 3rd Circuit Court of Appeals erred in reversing a lower court decision...[ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes one medical product company Becton Dickinson.