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Ileus Added to Ozempic Label Adverse Effects

[ Price : $8.95]

CBS News says FDA has approved a labeling change for Novo Nordisks Ozempic to acknowledge reports of ileus following use of the dr...

Gilead Ends AML Trial of Magrolimab

[ Price : $8.95]

Gilead says it ended the ENHANCE-2 trial of magrolimab in acute myeloid leukemia with TP53 mutations after determining it would no...

Prescription Information Modernization Bill

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Sens. Mullins and Booker introduce bipartisan legislation to permit electronic transmission of drug prescribing information to hea...

Eye Dilation Reversal Drops Approved

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FDA approves a Viatris and Ocuphire Pharma NDA for Ryzumvi (phentolamine ophthalmic solution) 0.75% for treating pharmacologically...

Boston Scientifics AVVIGO+ Guidance Device Cleared

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FDA clears a Boston Scientific 510(k) for its AVVIGO+ Multi-Modality Guidance System, which the company describes as a streamlined...

Guide on Device Security Quality Considerations

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Federal Register notice: FDA makes available a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerat...

Comments Reopened on AI in Drug Manufacturing

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Federal Register notice: FDA reopens the comment period on a 3/1 notice entitled Discussion Paper: Artificial Intelligence in Drug...

Peace Wellness Marketing Tissue Products: FDA

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FDA says Phoenix-AZ-based Peace Wellness Center is marketing stem cell products and exosomes that require approval through a BLA o...

Philips Hid Breathing Machine Complaints: Report

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A ProPublica/Pittsburgh Post-Gazette in-depth report says Philips Respironics kept from FDA adverse event reports describing serio...

Nephron Pharma Hit Again with FDA-483

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A just-released Form FDA-483 shows that four months after a 10/2022 Warning Letter, the agency cited the firm again after an inspe...