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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

Bipartisan Brain Cancer Research Bill In

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

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Human Drugs

FDA to Phase Out Some Drug Animal Testing

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

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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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Biologics

Outlook Refiles BLA for Wet AMD Drug

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

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Human Drugs

Coordinate HHS Drug Shortage Activities: GAO

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

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Human Drugs

FDA OKs Dropping Tryvio REMS

FDA approves updated labeling for Idorsias blood pressure drug Tryvio after approving the elimination of a REMS requirement.

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FDA General

Raskin, Others Seek FDA Meeting on Cuts

Members of Congress from Maryland, led by Rep. Jamie Raskin, ask to meet with FDA commissioner Martin Makary to discuss their concerns about significa...

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FDA General

Kessler Slams Dangerous FDA Cuts at Hearing

Former FDA commissioner David Kessler tells a House hearing that recent FDA staff cuts will adversely affect the U.S.s public health and scientific le...