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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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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.

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Human Drugs

House GOPs Demand Clinical Data on Puberty Blockers

House Republicans demand the release of clinical data from taxpayer-funded research involving a study of puberty-blocking drugs that were not publishe...

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Federal Register

Info Collection on Antimicrobial Animal Drug Sales

Federal Register notice: FDA seeks comments on an information collection extension entitled Antimicrobial Animal Drug Sales and Distribution21 CFR 514...

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Human Drugs

Broader FDA Interpretations Needed for Review Vouchers: Hill

A bipartisan Congressional effort seeks broader FDA interpretations when awarding priority review vouchers.

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Human Drugs

FDA Sued Over Drug Compounding Restrictions

FarmaKeio Outsourcing, a drug compounding outfit, files a lawsuit against FDA seeking a court order to permit the compounding of sodium thiosulfate.