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Medical Devices

Registry Set Up for Breast Implant Carcinoma Reports

FDA says events involving squamous cell carcinoma in the scar tissue (capsule) that forms around breast implants should be reported to a registry deve...

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Human Drugs

Contradictory Info in P&G Nyquil Filing: FDA

FDA warns Procter & Gamble (P&G) about unresolved contradictory information in the electronic listing for one of its Nyquil products and the product l...

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Human Drugs

Incyte Accelerated Approval for Skin Cancer Drug

FDA grants Incyte accelerated approval of its BLA for Zynyz (retifanlimab-dlwr) for treating adults with metastatic or recurrent locally advanced Merk...

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Human Drugs

Steps Needed to Address Drug Shortages: Report

The Senate Homeland Security & Governmental Affairs majority staff issues a report recommending six things FDA, Congress, and other stakeholders can d...

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Human Drugs

Ways to Increase Clinical Trial Diversity: PhRMA

Pharmaceutical Research and Manufacturers of America tells the White House Office of Science and Technology Policy its three suggestions for enhancing...

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Medical Devices

Roche/Lilly Collaborate on Alzheimers Test

Roche and Eli Lilly collaborate to develop Roches Elecsys Amyloid Plasma Panel, a blood test designed for making earlier diagnoses of Alzheimers disea...

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Biologics

Biological Product Deviation Reports Up: CBER

The CBER FY 2022 biological product deviation reporting annual summary says there was a 3% increase in reports submitted over FY 2021.

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Marketing

Regulators Need to Keep Up with Patient Influencers: Study

A new University of Colorado Boulder study points to the need for FDA to work harder to follow and consider further regulating social media micro-infl...

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Biologics

Regenerons Evkeeza Expanded Use in Young Children

FDA approves an expanded indication for Regeneron Pharmaceuticals Evkeeza (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat c...

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Human Drugs

Consider Antitrust in Apokyn Generic Case: FTC

The Federal Trade Commission asks the Delaware federal court to consider four antitrust implications in deciding whether to grant a Supurnus motion to...