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FDA Clears RapidAI Intracranial Hemorrhage Triage Device

[ Price : $8.95]

FDA clears a RapidAI 510(k) for the latest release of Rapid ICH, an intracranial hemorrhage (ICH) triage and notification device.

Janssen Says Spravato Tops Seroquel in Trial

[ Price : $8.95]

Janssen says results of a head-to-head trial showed its Spravato had superior efficacy to Seroquel in patients with treatment-resi...

Controversy Seen in CDS Software Final Guidance

[ Price : $8.95]

Three Ropes & Gray attorneys describe some of the issues in a long-awaited FDA final guidance on clinical decision support softwar...

Alert on Prolia and Severe Hypocalcemia

[ Price : $8.95]

FDA probes the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients treated with Am...

Agency Updates Bulk Substances for Compounding List

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Federal Register notice: FDA is identifying two bulk drug substances that it has considered and proposes to include on its list of...

FDA Modeling, Simulation Successes

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The FDA Modeling and Simulation Working Group issues a report on how modeling and simulation are used within and across FDA Center...

GSK Pulls Blenrep Accelerated Approval at FDAs Request

[ Price : $8.95]

At FDAs request, GSK is withdrawing the accelerated approval for Blenrep (belantamab mafodotin-blmf) due to the therapys poor show...

Multiple Violations at Invitrx Therapeutics

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FDA warns Lake Forest, CA-based Invitrx Therapeutics about illegally marketing cellular and acellular products and CGMP and CGTP v...

Guide on Compounding Beta-Lactam Products

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Federal Register notice: FDA makes available a final guidance entitled Compounding Certain Beta-Lactam Products in Shortage Under ...

Latest Philips Respironics MDRs

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FDA reports on the latest three months of medical device reports on some Philips Respironics ventilators, BiPAP, and CPAP machines...