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FDA Approves Incytes Niktimvo

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FDA approves Incytes Niktimvo for some adult and pediatric host-versus-graft treatments.

Workshop on Measuring Gonadal Toxicity

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FDA and the American Society of Clinical Oncology announce a 10/1 joint workshop entitled Measuring Toxicity in Reproductive Organ...

Big Healths SleepioRx Cleared for Sleep Help

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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

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

Galderma BLA for Nemluvio Approved

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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

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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

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

QS, MDR Violations at Globus Medical

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

Proprietary Name Review MAPP

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