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Medical Devices

Contec and Epsimed Cybersecurity Patch

FDA says Contec has issued a software patch that resolves cybersecurity vulnerabilities in certain Contec and Epsimed patient monitors by removing net...

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Human Drugs

FDA: Website Selling Misbranded, Unapproved Drugs

FDA warns the owners of the www.buynetmeds.com Web site about selling misbranded and unapproved drug products in interstate commerce.

Medical Devices

Baxter: Remove Spectrum Infusion Pumps

FDA issues an Early Alert for a Baxter Spectrum infusion pump software issue.

Human Drugs

FDA Expands ER-Stimulant Labeling for Weight Loss

FDA orders Limitation of Use wording in labeling for extended-release stimulants used to treat ADHD to raise the risk of weight loss in children under...

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Human Drugs

Guidance on Aluminum Content in Parenteral Drugs

FDA issues a draft guidance entitled Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and L...

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FDA General

FDA Elsa Rollout a Nuanced Dance: Consultant

Consultant Erika Roberts says FDAs rollout of its staff AI tool Elsa is a good first step, but much more needs to be done to reach the potential of us...

Medical Devices

Sirtex Medical Wins Device OK for Liver Cancer

FDA approves a Sirtex Medical PMA for its SIR-Spheres Y-90 resin microspheres for treating unresectable hepatocellular carcinoma.

Biologics

Vacate RFK Jr. Covid Vaccine Recommendations: Lawsuit

A group of medical societies files suit against HHS secretary Robert F. Kennedy Jr. and FDA commissioner Marty Makary to reverse a 5/27 decision to re...

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Human Drugs

FDA Oxylanthanum Carbonate Complete Response Letter

FDA issues a complete response letter to Unicycive Therapeutics for its hyperphosphatemia drug oxylanthanum carbonate that cites issues with a manufac...

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Human Drugs

FDA Accelerated Approval for Dizal Zegfrovy

FDA gives accelerated approval to Dizals lung cancer drug Zegfrovy, along with a companion diagnostic device.