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Medical Devices

FDA Approves Humacytes Symvess

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

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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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Human Drugs

Lexicon Dropping Zynquista After CRL

Lexicon stops development of its diabetes drug Zynquista that received an FDA complete response letter.

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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

Sombra Cosmetics CGMP Violations

FDA warns Albuquerque, NM-based Sombra Cosmetics about CGMP violations in the manufacturing of finished drugs.

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Human Drugs

FDA OKs Mesoblasts Ryoncil Cell Therapy

FDA approves Mesoblasts Ryoncil to treat some graft-versus-host disease pediatric patients.