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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

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.

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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.

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Federal Register

Glaucoma Pressure Reducer Goes to Panel

Federal Register notice: FDA announces a 3/21 advisory committee meeting to discuss a de novo marketing request by Balance Ophthalmics for its intraoc...

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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...