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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 ...

ZyVersa Touts Approval Path for Kidney Disorder Drug

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ZyVersa Therapeutics says a new regulatory development could significantly shorten the path to approval for treatments targeting f...

FDA Like Flat Earthers Taking Over NASA: Woodcock

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Three former FDAers warn of a slow-moving catastrophe coming for the agency as it loses staff and resources under leaders who have...

FDA OKs Opdivo/Yervoy in Colon Cancer

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FDA approves Bristol Myers Squibbs combination of Opdivo (nivolumab) with Yervoy (ipilimumab) for treating certain adult and pedia...

Multiple Violations at EpiCare Acquisitions

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FDA warns Lawrenceville, NJ-based EpiCare Acquisitions about Quality System and other violations in its manufacturing of a family ...