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FDA General

Biomedical Industry Seeks Senate Help on FDA Cuts

Hundreds of U.S. biomedical innovators and investors urge the Senate to help restore critical FDA staff that were recently laid off so that institutio...

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Human Drugs

J&J Reports Favorable Data on Psoriasis Drug

Johnson & Johnson reports new icotrokinra (JNJ-2113) data from a Phase 3 studys subgroup analysis in moderate-to-severe plaque psoriasis patients.

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FDA General

Information Bottleneck Due to FDA Staff Cuts: Analysis

Two Hyman, Phelps & McNamara attorneys say reductions in staff at FDA are resulting in significant delays in agency responses to Freedom of Informatio...

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FDA General

FDA to Allow Some Teleworking: AP

The Associated Press says FDA has reversed course and will permit some product reviewers and supervisors to work from home at least two days per week.

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Human Drugs

Alzheon Alzheimers Trial Misses Primary Endpoint

Alzheon says its Phase 3 valiltramiprosate trial in early Alzheimers disease patients did not meet its primary endpoint of slowing cognitive decline.

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Medical Devices

FDA Clears Dexcom Glucose Monitor

FDA clears the Dexcom G7 15 Day continuous glucose monitoring system.

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Medical Devices

FDA Clears Intuitive Stapler for da Vinci Robot

FDA clears an Intuitive 510(k) for the SP SureForm 45 stapler for use with its da Vinci SP surgical system in thoracic, colorectal, and urologic proce...

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Human Drugs

Support, Suggestions for FDA Regulatory AI Guidance

Two stakeholders voice support for an FDA draft guidance on using AI in drug and biologic regulatory decision-making and ask for additional informatio...

Medical Devices

Zeiss Medical Gets Clearance for Intrabeam 700

FDA clears a Zeiss Medical Technology 510(k) for its Intrabeam 700, a robotic-assisted platform to support intraoperative radiation therapy.