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Medical Devices

FDA Clears Hearing Aid/Smart Glasses

FDA clears an EssilorLuxottica 510(k) for its over-the-counter Nuance Audio Glasses that provide an open-ear hearing solution integrated into a pair o...

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Medical Devices

Gyder Hip System Cleared by FDA

FDA clears a Gyder Surgical 510(k) for the Gyder Hip System and its use in positioning the acetabular cup during hip replacement surgeries.

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Human Drugs

Vertex Non-Opioid New Pain Drug Approved

FDA approves a Vertex Pharmaceuticals NDA for Journavx (suzetrigine), a first-in-class non-opioid pain drug for treating moderate to severe acute pain...

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Federal Register

Info Collection on Rx Labeling Requirements

Federal Register notice: FDA sends to OMB an information collection revision entitled Labeling Requirements for Prescription Drugs.

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Federal Register

Biosimilar User Fees Info Collection Revised

Federal Register notice: FDA sends to OMB an information collection revision entitled Biosimilars User Fee Program.

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Human Drugs

FDA Alert on Fresenius Kabi Infusion Pumps

An FDA alert advises healthcare providers about Fresenius Kabis Ivenix large-volume pumps and their increased chance of issuing a non-recoverable pump...

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Human Drugs

Neo-Tee T-Piece Resuscitators Recalled

Mercury Medical recalls its Neo-Tee T-Piece resuscitator due to a small spring in the controller that may prevent the device from delivering the requi...

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Biologics

Guide on Reducing Sepsis from Cell/Tissue Products

FDA posts a final guidance entitled Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissue...

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Human Drugs

Senators Urge PhRMA to Support DTC Advertising Bill

Senators Chuck Grassley (R-IA) and Dick Durbin (D-IL) urge the Pharmaceutical Research and Manufacturers of America to support their bipartisan Drug-p...

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Human Drugs

Inhibikase Therapeutics Pulls Plug on Parkinsons Drug

Inhibikase Therapeutics pauses further development of risvodetinib and its use in untreated Parkinsons disease due to disappointing Phase 2 study data...