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FDA Clears Hearing Aid/Smart Glasses

[ Price : $8.95]

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

Gyder Hip System Cleared by FDA

[ Price : $8.95]

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

Vertex Non-Opioid New Pain Drug Approved

[ Price : $8.95]

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

Info Collection on Rx Labeling Requirements

[ Price : $8.95]

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

Biosimilar User Fees Info Collection Revised

[ Price : $8.95]

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

FDA Alert on Fresenius Kabi Infusion Pumps

[ Price : $8.95]

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

Neo-Tee T-Piece Resuscitators Recalled

[ Price : $8.95]

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

Guide on Reducing Sepsis from Cell/Tissue Products

[ Price : $8.95]

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

Senators Urge PhRMA to Support DTC Advertising Bill

[ Price : $8.95]

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

Inhibikase Therapeutics Pulls Plug on Parkinsons Drug

[ Price : $8.95]

Inhibikase Therapeutics pauses further development of risvodetinib and its use in untreated Parkinsons disease due to disappointin...