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Human Drugs

FDA OKs Pfizers Bosulif for Pediatric CML

FDA approves a new indication for Pfizers Bosulif to treat some pediatric patients with chronic myelogenous leukemia.

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Human Drugs

Ileus Added to Ozempic Label Adverse Effects

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

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Human Drugs

Gilead Ends AML Trial of Magrolimab

Gilead says it ended the ENHANCE-2 trial of magrolimab in acute myeloid leukemia with TP53 mutations after determining it would not provide a benefit ...

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Human Drugs

Prescription Information Modernization Bill

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

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Human Drugs

Eye Dilation Reversal Drops Approved

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

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Medical Devices

Boston Scientifics AVVIGO+ Guidance Device Cleared

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

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Federal Register

Guide on Device Security Quality Considerations

Federal Register notice: FDA makes available a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of ...

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Federal Register

Comments Reopened on AI in Drug Manufacturing

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

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Biologics

Peace Wellness Marketing Tissue Products: FDA

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

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Medical Devices

Philips Hid Breathing Machine Complaints: Report

A ProPublica/Pittsburgh Post-Gazette in-depth report says Philips Respironics kept from FDA adverse event reports describing serious issues with its C...