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Human Drugs

Mylan 6-Item Form FDA-483 Posted

FDA posts a six-item Form FDA-483 that led to a 12/19 Warning Letter to Mylan Laboratories citing its Pradesh, India manufacturing facility.

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Human Drugs

FDA Approves Checkpoints Unloxcyt

FDA approves Checkpoint Therapeutics Unloxcyt to treat some squamous cell cancer patients.

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Human Drugs

FDA Approves Xcoverys Ensacove for Some Lung Cancers

FDA approves Xcoverys Ensacove, an anaplastic lymphoma kinase inhibitor, to treat some non-small cell lung cancers.

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Medical Devices

FDA Approves Humacytes Symvess

FDA approves Humacytes Symvess for use with some extremity arterial injuries.

Human Drugs

Hidden Ingredient in Rhino 11 Gummies: FDA

FDA recommends that consumers not purchase or use Rhino 11 gummies due to the presence of undeclared tadalafil.

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Medical Devices

FDA Alert on Boston Accolade Pacers Early Replacement

FDA alerts patients, caregivers, and healthcare providers to the potential for some Boston Scientific Accolade pacemakers to need replacement early.

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Human Drugs

Bhargava Phytolab CGMP Violations

FDA warns Indias Bhargava Phytolab about CGMP issues in its manufacturing of finished drugs and active pharmaceutical ingredients.

Human Drugs

Endo Recalls Adrenalin Chloride Solution

FDA says Endo USA has recalled its Adrenalin Chloride Solution that predates the Federal Food, Drug, and Cosmetic Act and was never submitted for FDA ...

Human Drugs

FDA Warns 4 Online GLP-1 Sellers

FDA warns four companies it says are marketing unapproved copies of popular weight loss drugs.

Medical Devices

Global Unique Device ID Database Guidance

FDA publishes an updated Global Unique Device Identification Database guidance.