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J&J Reports Favorable Data on Psoriasis Drug

[ Price : $8.95]

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

Information Bottleneck Due to FDA Staff Cuts: Analysis

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

FDA to Allow Some Teleworking: AP

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The Associated Press says FDA has reversed course and will permit some product reviewers and supervisors to work from home at leas...

Alzheon Alzheimers Trial Misses Primary Endpoint

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

FDA Clears Dexcom Glucose Monitor

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

FDA Clears Intuitive Stapler for da Vinci Robot

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

Support, Suggestions for FDA Regulatory AI Guidance

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Two stakeholders voice support for an FDA draft guidance on using AI in drug and biologic regulatory decision-making and ask for a...

Zeiss Medical Gets Clearance for Intrabeam 700

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

Generic Policy Shop Cuts will Hurt ANDAs: Post

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Hyman, Phelps & McNamara attorney Kurst Karst says recent staff cuts at FDA that eradicated the Office of Generic Drugs Division o...