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Medical Devices

GE Healthcare EVair Recall Actions No Longer Apply: FDA

FDA says GE Healthcare has determined there is no risk of elevated levels of formaldehyde from using its EVair compressor and restrictions on its use ...

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Human Drugs

Protega Abuse-Deterrent Oxycodone Approved

FDA approves Protega Pharmaceuticals Roxybond (oxycodone hydrochloride), an abuse-deterrent, immediate-release 10 mg tablet for managing pain.

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Human Drugs

Canadian Drug Imports Wont Help U.S.: Study

A Canadian Health Policy Institute analysis says U.S. drug importation programs developed by state governments will not be able to achieve the consume...

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Human Drugs

Novartis Wins Expanded Approval for Scemblix

FDA grants an accelerated approval to Novartis for its supplemental NDA for Scemblix (asciminib) for the drugs expanded use in treating newly diagnose...

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FDA General

Trump as President May Tap RFK for FDA Head

Former president Donald Trump appears to be leaning toward elevating former presidential candidate and now supporter Robert F. Kennedy, Jrs health rol...

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Human Drugs

FDA Wont Require Qsymia CV Outcome Trial

FDA says it no longer requires a cardiovascular outcome trial for Vivus Qsymia weight-loss pill.

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Human Drugs

PharmaTher Complete Response Letter on Ketamine

FDA sends PharmaTher a complete response letter on its ANDA for Ketarx (ketamine) and its use in anesthesia, sedation, and pain, among other uses.

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Medical Devices

De Novo Authorization for Dexter Surgical Robot

FDA grants Distalmotion a de novo marketing authorization for the Dexter Surgical Robot for adult inguinal hernia repair.

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Medical Devices

Paragonix Kidney Preservation Transport Device Cleared

FDA clears a Paragonix Technologies 510(k) for its transportable perfusion device KidneyVault and its use in kidney preservation.