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More ORA Changes Coming

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

FDA OKs Bayers Ultravist for Mammography

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

FibroGen Quashes Pulmonary Fibrosis Trial

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FibroGen discontinues its ZEPHYRUS-2 Phase 3 trial of pamrevlumab in patients with idiopathic pulmonary fibrosis after topline dat...

Draft Guide on Medical Psychedelic Drugs

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Federal Register notice: FDA posts a draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations.

ReShape Lifesciences sPMA for Lap-Band 2.0

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

FDA Approves Pfizer Alopecia NDA

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

UCB Psoriasis BLA Review Extended

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

CS Medical Ultrasound Probe Cleaner Cleared

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

Hold Lifted on Pharvaris Angioedema Drug

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

Pfizer Dumps Lotiglipron on Liver Injury Concerns

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Citing potential liver injury concerns, Pfizer says it is terminating the development program for glucagon-like peptide-1 receptor...