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Medical Devices

Implant Sales Rep Arrested in Fraud Case

The U.S. government arrests former DePuy Synthes sales representative Matthew Capobianco on eight counts of wire fraud and one count of making false s...

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FDA General

More ORA Changes Coming

FDA announces additional changes in the way the Office of Regulatory Affairs operates.

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Human Drugs

FDA OKs Bayers Ultravist for Mammography

FDA approves Bayers Ultravist (iopromide)-300 and Ultravist-370, iodine-based contrast agents for contrast-enhanced mammography.

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Human Drugs

FibroGen Quashes Pulmonary Fibrosis Trial

FibroGen discontinues its ZEPHYRUS-2 Phase 3 trial of pamrevlumab in patients with idiopathic pulmonary fibrosis after topline data from the earlier Z...

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Federal Register

Draft Guide on Medical Psychedelic Drugs

Federal Register notice: FDA posts a draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations.

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Medical Devices

ReShape Lifesciences sPMA for Lap-Band 2.0

ReShape Lifesciences files a PMA supplement for the companys next generation Lap-Band 2.0 for long-term treatment of obesity.

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Human Drugs

FDA Approves Pfizer Alopecia NDA

FDA approves a Pfizer NDA for Litfulo (ritlecitinib), a once-daily oral treatment for individuals 12 years of age and older with severe alopecia areat...

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Biologics

UCB Psoriasis BLA Review Extended

FDA extends its review of UCB's psoriasis drug bimekizumab for reasons the company did not disclose.

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Medical Devices

CS Medical Ultrasound Probe Cleaner Cleared

FDA clears a CS Medical 510(k) for its Ethos Automated Ultrasound Probe Cleaner Disinfector.

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Human Drugs

Hold Lifted on Pharvaris Angioedema Drug

FDA lifts a Pharvaris clinical hold on a deucrictibant clinical trial for the on-demand treatment of hereditary angioedema attacks.