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Big Healths SleepioRx Cleared for Sleep Help

[ Price : $8.95]

FDA clears a Big Health 510(k) for its SleepioRx, a digital therapeutic intended for treating chronic insomnia/insomnia disorder a...

Peripheral/CNS Drugs Panel Renewed

[ Price : $8.95]

Federal Register notice: FDA renews for two years its Peripheral and Central Nervous System Drugs advisory committee.

Galderma BLA for Nemluvio Approved

[ Price : $8.95]

FDA approves a Galderma BLA for Nemluvio (nemolizumab), a pre-filled pen for subcutaneous injection for adults with prurigo nodula...

Objectionable Conditions in Doctors Clinical Trial

[ Price : $8.95]

FDA warns Lublin, Poland, physician Konrad Rejdak about Bioresearch Monitoring violations in a clinical study for which he was the...

Nowrez & Ismail Shukri CGMP Violations

[ Price : $8.95]

FDA warns Jordans Nowrez and Ismail Shukri Company about CGMP violations in the production of OTC drugs.

QS, MDR Violations at Globus Medical

[ Price : $8.95]

FDA warns Globus Medical about Quality System and Medical Device Reporting violations in its production of the Excelsius GPS surgi...

Proprietary Name Review MAPP

[ Price : $8.95]

A CDER Manual of Policies and Procedures lists responsibilities for the Office of Surveillance and Epidemiology and other CDER off...

Tandem Diabetes Insulin Pump App Recall

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Tandem Diabetes Care updates its March recall of its Apple iOS t:connect mobile app in the U.S. due to an issue that can cause rap...

Creating Hope Reauthorization Act Introduced

[ Price : $8.95]

Sen Susan Collins and a bipartisan group of her colleagues introduce the Creating Hope Reauthorization Act to extend until 2030 th...

Change Biological Drug Monographs: Petition

[ Price : $8.95]

A University of Illinois Chicago College of Pharmacy petition calls on FDA to authorize a new form of monograph for biological pro...