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Positive Phase 3 Results for Moderna Flu Vaccine

[ Price : $8.95]

Moderna says its mRNA-1010 investigational seasonal flu vaccine achieved very positive results in a Phase 3 efficacy trial.

Bioresearch Monitoring Violations by Dr. Peter Michael

[ Price : $8.95]

FDA warns Hialeah, FL-based physician Peter Michael about failing to follow the investigation plan in two clinical studies.

Regenerons Lynozyfic Approved for Some Myelomas

[ Price : $8.95]

FDA gives accelerated approval to Regenerons Lynozyfic for some multiple myelomas.

Healwell Homeo Private Selling Adulterated Drugs: FDA

[ Price : $8.95]

FDA warns Indias Healwell Homeo Private Limited about producing adulterated homeopathic and OTC drugs with CGMP violations.

Contec and Epsimed Cybersecurity Patch

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FDA says Contec has issued a software patch that resolves cybersecurity vulnerabilities in certain Contec and Epsimed patient moni...

FDA: Website Selling Misbranded, Unapproved Drugs

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

Baxter: Remove Spectrum Infusion Pumps

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

FDA Expands ER-Stimulant Labeling for Weight Loss

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

Guidance on Aluminum Content in Parenteral Drugs

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FDA issues a draft guidance entitled Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Al...

FDA Elsa Rollout a Nuanced Dance: Consultant

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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...