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Biomedical Industry Seeks Senate Help on FDA Cuts

[ Price : $8.95]

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

[ Price : $8.95]

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...

FDA OKs Dropping Tryvio REMS

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

Raskin, Others Seek FDA Meeting on Cuts

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

Kessler Slams Dangerous FDA Cuts at Hearing

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

Device Approvals Slow to 10-Year Low: Report

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The Minneapolis Star Tribune says medical device companies are concerned that FDA layoffs have resulted in fewer device approvals ...

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Two stakeholders voice support for an FDA draft guidance on using AI in drug and biologic regulatory decision-making and ask for a...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