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Medical Devices

Percussionaire Recalls Breathing Circuit Kits

Percussionaire recalls its High Frequency Transport Phasitron Breathing Circuit Kits due to a product defect that causes over-pressurization.

Biologics

Valneva Sells FDA Voucher for $103 Million

Valneva says it has sold an FDA tropical disease priority review voucher for $103 million that it will use to fund research and development efforts.

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Medical Devices

Boston Scientifics Spinal Cord Stimulator Wins 50% Pain Cut OK

FDA approves a 50% pain reduction indication for Boston Scientifics WaveWriter Spinal Cord Stimulator in treating chronic low back and leg pain.

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Federal Register

Guide on Reporting Drug Making Amounts

Federal Register notice: FDA makes available a final guidance entitled Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3...

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Human Drugs

FDA Again Cites Catalent Facility

Bloomberg News reports that FDA inspectors found problems at a Catalent Indiana facility that is being bought by Novo Nordisk to expand the supply of ...

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Human Drugs

Study on Enhancing Weight-Loss Drugs

FDA approves a Veru IND to begin a Phase 2b clinical study to evaluate enobosarm and its use in preserving muscle mass and physical function and incre...

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Human Drugs

Centera, CEO Sentenced Over Unapproved Drugs

A federal court sentences Arizona-based Centera Bioscience and CEO Paul Eftang for distributing unapproved drugs into interstate commerce.

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Human Drugs

J&J Reports Positive Data on Nipocalimab

Johnson & Johnson reports positive data from two studies involving its monoclonal antibody nipocalimab, supporting the drugs potential use in generali...

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Human Drugs

Guidance on Reporting Listed Drug Amounts

FDA posts a final guidance entitled Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.

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Human Drugs

Ainos Responds to Clinical Hold on Covid Therapy

Ainos files a clinical hold response seeking to begin a Phase 2 trial of its low-dose oral interferon (IFN)-alpha formulation Veldona.