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Nanowear Wearable Diagnostic Cleared

[ Price : $8.95]

FDA clears a Nanowear 510(k) for the companys SimpleSense, a nanotechnology-enabled wearable and software platform.

Novartis Radioligand Manufacturing Site Approved

[ Price : $8.95]

FDA approves Novartis Radioligand Therapy manufacturing facility in Indianapolis, IN, to produce prostate cancer therapy Pluvicto....

Vaccine Hesitancy Threatening Public Health: FDA

[ Price : $8.95]

FDA leaders say anti-vaxxers and those that are vaccine-hesitant due to safety concerns or religious beliefs are threatening U.S. ...

ModernaTX Hit with 483 Over GMPs

[ Price : $8.95]

FDA issues ModernaTX a five-item Form FDA-483 after a 09/11-21/2023 inspection documented GMP violations.

Rep. Murphy Wants FDA Artificial Intelligence Info

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Rep. Gregory Murphy asks FDA for its views on several aspects of using artificial intelligence in medical care as a prelude to reg...

Wound Dressing Change Kit Recalled

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ROi CPS of Republic, MO, recalls its Regard Wound Dressing change kit due to it containing nonconforming material/component.

Document on Guidance Best Practices

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Federal Register notice: FDA makes available a draft document entitled Food and Drug Administrations Draft Report and Plan on Best...

Latest Safety Signal Report Includes Ozempic, Others

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FDA says it is evaluating the need for regulatory action after seeing a safety signal for some additional side effects in GLP-1 re...

Siemens New MR Whole-Body Scanner Cleared

[ Price : $8.95]

FDA clears a Siemens Healthineers 510(k) for the MAGNETOM Cima.X 3 Tesla (3T) magnetic resonance imaging whole-body scanner.

Hold Lifted on Innate Lymphoma Trials

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FDA removes a partial clinical hold placed on Innate Pharma's Phase 2 TELLOMAK and Phase 1b PTCL trials of lacutamab in cutaneous ...