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Priority Voucher Used on AbbVies Skyrizi

[ Price : $8.95]

Federal Register notice: FDA announces that a priority review voucher was redeemed 6/16 by AbbVie for a supplemental BLA for Skyri...

FDA Waives Panel Meeting on Biomarin Gene Therapy

[ Price : $8.95]

FDA tells BioMarin Pharmaceutical that it no longer plans to hold an advisory committee meeting to review the companys resubmitted...

WatchCare Incontinence Management System Recall Class 1

[ Price : $8.95]

FDA says the Baxter Hillrom recall of WatchCare Incontinence Management Systems is Class 1.

Controversy Seen in CDS Software Final Guidance

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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

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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

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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 ...