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FDA Launches TEMPO: A First-of-Its-Kind Digital Health Pilot to Expand Access to Chronic Disease Technologies

Murilo Freitas - 20:15, 4 de December de 2025188
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FDA Launches TEMPO: A First-of-Its-Kind Digital Health Pilot to Expand Access to Chronic Disease Technologies
http://www.fda.gov/news-events/press-announcements/fda-launches-tempo-first-its-kind-digital-health-pilot-expand-access-chronic-disease-technologies

 
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FDA Approves First CAR T-Cell Therapy for Marginal Zone Lymphoma In the US

Murilo Freitas - 21:55, 3 de December de 202534
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FDA Approves First CAR T-Cell Therapy for Marginal Zone Lymphoma In the US
http://www.fda.gov/news-events/press-announcements/fda-approves-first-car-t-cell-therapy-marginal-zone-lymphoma-us

 
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FDA Conditionally Approves Topical Drug for Cattle for New World Screwworm and Cattle Fever Tick

Murilo Freitas - 16:16, 3 de December de 202534
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FDA Conditionally Approves Topical Drug for Cattle for New World Screwworm and Cattle Fever Tick
http://www.fda.gov/news-events/press-announcements/fda-conditionally-approves-topical-drug-cattle-new-world-screwworm-and-cattle-fever-tick

 
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FDA Announces Leadership Appointments at Center for Drug Evaluation and Research

Murilo Freitas - 23:44, 2 de December de 202599
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FDA Announces Leadership Appointments at Center for Drug Evaluation and Research
http://www.fda.gov/news-events/press-announcements/fda-announces-leadership-appointments-center-drug-evaluation-and-research

 
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FDA Approves Nerve Scaffold for the Treatment of Sensory Nerve Discontinuity

Murilo Freitas - 23:22, 2 de December de 2025133
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FDA Approves Nerve Scaffold for the Treatment of Sensory Nerve Discontinuity
http://www.fda.gov/news-events/press-announcements/fda-approves-nerve-scaffold-treatment-sensory-nerve-discontinuity

 
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Correction Alert: Olympus Updates Use Instructions for Ligating Device

Murilo Freitas - 05:00, 2 de December de 2025110
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Olympus ligation loops may be unable to release or detach as expected during use and may become unintentionally anchored around patient anatomy
 

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/correction-alert-olympus-updates-use-instructions-ligating-device

 
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FDA Seizes 7-OH Opioids to Protect American Consumers

Murilo Freitas - 21:41, 1 de December de 202567
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FDA Seizes 7-OH Opioids to Protect American Consumers
http://www.fda.gov/news-events/press-announcements/fda-seizes-7-oh-opioids-protect-american-consumers

 
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FDA Releases Draft Guidance on Reducing Testing on Non-Human Primates for Monoclonal Antibodies

Murilo Freitas - 14:58, 1 de December de 202547
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FDA Releases Draft Guidance on Reducing Testing on Non-Human Primates for Monoclonal Antibodies
http://www.fda.gov/news-events/press-announcements/fda-releases-draft-guidance-reducing-testing-non-human-primates-monoclonal-antibodies

 
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Early Alert: Glucose Monitor Sensor Issue from Abbott Diabetes Care

Murilo Freitas - 05:00, 1 de December de 2025117
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Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may provide incorrect low glucose readings

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-glucose-monitor-sensor-issue-abbott-diabetes-care

 
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FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment

Murilo Freitas - 20:04, 30 de November de 2025101
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FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment
http://www.fda.gov/news-events/press-announcements/fda-expands-artificial-intelligence-capabilities-agentic-ai-deployment

 
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