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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...

Bipartisan Brain Cancer Research Bill In

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A bipartisan group of Senate and House members introduce legislation to advance research into brain cancer and improve care for br...

FDA to Phase Out Some Drug Animal Testing

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FDA says it intends to phase out animal testing in the development of monoclonal antibodies and some other drugs.

Biomedical Industry Seeks Senate Help on FDA Cuts

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

Outlook Refiles BLA for Wet AMD Drug

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FDA accepts for review an Outlook Therapeutics BLA resubmission for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic for...

Coordinate HHS Drug Shortage Activities: GAO

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The Government Accountability Office says HHS should have some mechanism in place to coordinate the activities of various HHS agen...