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MaaT013 Clinical Hold Still in Place

[ Price : $8.95]

FDA says its clinical hold on a MaaT Pharma Phase 3 trial of an investigational graft-versus-host disease drug remains in place wh...

Info Collection on Mammography Quality Standards

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled "Mammography Quality Standards Act Req...

Info Collection on Environmental Impact Considerations

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Federal Register notice: FDA sends to OMB an information collection revision entitled: "Environmental Impact Considerations."

Medical Device Accessories Information Collection

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled "Medical Device Accessories."

BD Intraosseous Devices Class 1 Recall

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FDA says the Becton Dickinson recall of three intraosseous medical devices is Class 1.

Menarini/Radius Submit Breast Cancer NDA

[ Price : $8.95]

The Menarini Group, supported by Radius Health, submits an NDA to FDA for elacestrant to treat some breast cancers.

FDA Covid Test Recommendations Based on UMass Study

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The UMass Chan Medical School says the results of its study of at-home Covid tests are in an FDA recommendation for serial testing...

Ex-FDA Court Expert Witness Challenged

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The federal court hearing a proton-pump inhibitor liability consolidated case is considering whether a former FDAer who was involv...

Novartis Gets Full Approval for Tabrecta

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FDA grants full approval to Novartis for its previously accelerated-approved Tabrecta (capmatinib) for treating certain adult pati...

ClearPoint Neuro Brain Visualizer Cleared

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FDA clears a ClearPoint Neuro 510(k) for its ClearPoint Maestro Brain Model, software that uses MRI images to conduct labeling, vi...