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Human Drugs

Soleno Study Change Might Answer Questions: FDA

FDA tells Soleno Therapeutics that a change in study design for its Prader-Willi treatment NDA has the potential to answer agency questions about the ...

Human Drugs

Draft Dose Banding Guidance Out

FDA publishes a draft drug banding guidance.

Medical Devices

FDA Warning on Ultraviolet Wands for Disinfecting

FDA issues a safety warning about certain brands of ultraviolet wands used for disinfecting surfaces because the devices may expose users and others t...

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Marketing

Many Drug Field Contacts In Person Again: Veeva Report

The Veeva Field Trends 2022 report says 75% of healthcare providers want contact with drug field staff to be a mix of digital and in-person.

Medical Devices

Transcranial Magnetic Stimulation Cleared for Anxiety

FDA clears a Neuronetics 510(k) for a new indication for its NeuroStar Advanced Therapy for Mental Health device, a transcranial magnetic stimulation ...

Human Drugs

CGMP Deviations at Bioiberica

FDA warns Spains Bioiberica about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

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Human Drugs

False/Misleading Claims for Imprimis Rx Compounded Drugs: FDA

FDA warns Imprimis Rx that professional promotional materials for a compounded ophthalmic drug make false and misleading statements about the drug.

Human Drugs

Clinical Hold Lifted on Viking X-ALD Trial

FDA lifts a clinical hold against Viking Therapeutics VK0214 in patients with X-linked adrenoleukodystrophy.

Human Drugs

Merck Hits Brakes on Lynparza in Colorectal Cancer

Merck halts a Phase 3 LYNK-003 trial investigating Lynparza (olaparib) with or without bevacizumab for treating patients with unresectable or metastat...

Human Drugs

CDERs Cavazzoni Adds Deputy for Substance Abuse

CDER director Patrizia Cavazzoni selects associate director for controlled substances Marta Sokolowska to serve as deputy Center director for substanc...