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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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Federal Register

EUAs Revoked for 2 Covid Tests

Federal Register notice: FDA revokes the Emergency Use Authorizations for two Covid-19 tests issued to Southern California Permanente Medical Group an...

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Medical Devices

Cardinal Health Recalls Urology/Operating Trays

Due to an earlier Nurse Assist, LLC product recall, Cardinal Health is recalling products supplied to it for use in Covidien and Cardinal Health brand...

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Human Drugs

Vertex Plans Mid-year Cystic Fibrosis NDA

Vertex Pharmaceuticals plans to file an NDA by mid-year and use a priority review voucher for its cystic fibrosis combination drug, once-daily vanzaca...

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Human Drugs

Insight Recalls TING Athletes Foot Spray

Insight Pharmaceuticals recalls two lots of its TING 1% Tolnaftate Athletes Foot Spray Antifungal Spray Liquid due to elevated benzene levels.