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Brands International Limits, Delays Inspection: FDA

[ Price : $8.95]

FDA warns a Canadian Brands International facility about limiting and delaying an inspection that also identified CGMP violations.

CRL for Zealands SBS Treatment NDA

[ Price : $8.95]

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

Quality, Data Issues at Mylan Facility in India

[ Price : $8.95]

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

Boxed Warning for Veozah Liver Injury

[ Price : $8.95]

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

Lexicon Dropping Zynquista After CRL

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

Hologic BioZorb Marker Recall Class 1: FDA

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

UCB Minzasolmin Parkinsons Study Misses Endpoints

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

FDA Alert on Baxter Solution Sets

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

NEWSROOM CLOSED FOR THE HOLIDAYS

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FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Thursday, Jan 2, 2025.

Zimmer Biomet Stemless Shoulder System

[ Price : $8.95]

FDA clears a Zimmer Biomet 510(k) for the OsseoFit Stemless Shoulder System for total shoulder replacement.