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Human Drugs

Using AI in Tumor Assessment

A Friends of Cancer Research white paper explores the emerging role of AI-enabled tumor assessment tools and the framework needed to use them in valid...

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Human Drugs

Roche Reports Positive Phase 2 Data for Obesity Drug

Roche says its experimental dual GLP-1/GIP receptor agonist CT-388 delivered substantial and statistically significant weight loss in a Phase 2 study ...

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FDA Enforcement Year in Review

A Ropes & Gray year-end review examines significant changes in FDA and Justice Department enforcement actions pertaining to regulated industries and s...

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Human Drugs

FDA Lifts Clinical Hold on Intellias Phase 3 Trial

FDA lifts a clinical hold on Intellia Therapeutics MAGNITUDE-2 Phase 3 trial evaluating nexiguran ziclumeran for patients with hereditary transthyreti...

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Medical Devices

Warning Letter Issued to Meridian Bioscience

FDA sends a Warning Letter to Meridian Bioscience over serious quality system violations involving blood lead testing devices manufactured by its subs...

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Medical Devices

FDA Warns MAST Biosurgery Over Manufacturing Violations

FDA issues MAST Biosurgery a Warning Letter after an August inspection cited serious manufacturing quality and safety reporting violations related to ...

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Human Drugs

Drug Companies Using AI to Speed Submissions

Reuters reports that several drug companies say they are using artificial intelligence tools to speed up some of the time-intensive work needed for cl...

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Biologics

Scancell Advancing iSCIB1+ Into Phase 3 Melanoma Trial

FDA approves a Scancell Holdings IND to begin a registrational Phase 3 trial of iSCIB1+ in patients with advanced melanoma.

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Human Drugs

Former CytoDyn CEO Sentenced to Prison

A federal judge sentences former CytoDyn chief executive Nader Pourhassan to 30 months in prison for misleading investors about the development of an ...

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Human Drugs

FDA Cites Pine Pharma Over Sterility, Quality Control

FDA cites Pine Pharmaceuticals for multiple quality and sterility violations following a 10-day inspection of the companys drug outsourcing facility i...