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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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Medical Devices

Hologic BioZorb Marker Recall Class 1: FDA

FDA says a Hologic 3/2024 recall correction of BioZorb Markers was Class 1.

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Human Drugs

UCB Minzasolmin Parkinsons Study Misses Endpoints

UCB says it is ending the development of minzasolmin, a drug it was working on with Novartis to treat early Parkinsons disease, after the drug missed ...

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Medical Devices

FDA Alert on Baxter Solution Sets

FDA issues an alert against the use of certain Baxter Solution Sets with Duo-Vent Spikes because they were incorrectly assembled with inverted slide c...

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Human Drugs

CRL for Zealands SBS Treatment NDA

FDA issues a complete response letter for Zealands glepaglutide intended to treat short bowel syndrome.

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Human Drugs

Quality, Data Issues at Mylan Facility in India

FDA warns a Viatris Mylan drug manufacturing facility in Pradesh, India, about CGMP violations involving quality and data issues.

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Human Drugs

Boxed Warning for Veozah Liver Injury

FDA adds a liver injury Boxed Warning to labeling for Astellas menopause hot flash drug Veozah.

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FDA General

Temple Retires; Bumpus Leaves FDA

CDER senior advisor for clinical science Bob Temple retires, and FDA principal deputy commissioner Namandj Bumpus leaves the agency ahead of the new i...