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Biologics

Positive Phase 3 Results for Moderna Flu Vaccine

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

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Human Drugs

Bioresearch Monitoring Violations by Dr. Peter Michael

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

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Human Drugs

Regenerons Lynozyfic Approved for Some Myelomas

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

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Biologics

InVia Fertility Specialists HCT/Ps Violations

FDA warns Hoffman Estates, IL-based InVia Fertility Specialists about multiple violations of regulations governing human cells, tissues, and cellular ...

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Human Drugs

Healwell Homeo Private Selling Adulterated Drugs: FDA

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

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FDA issues a draft guidance entitled Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and L...