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UCB Minzasolmin Parkinsons Study Misses Endpoints

[ Price : $8.95]

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...

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

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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

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

Sombra Cosmetics CGMP Violations

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

FDA OKs Mesoblasts Ryoncil Cell Therapy

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

ICH M15 Model-Informed Drug Development Principles

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FDA publishes an International Council for Harmonization draft M15 guidance on model-informed drug development principles.

AMT Designation Program Guidance

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FDA publishes a guidance with recommendations for participating in the agencys Advanced Manufacturing Technologies Designation Pro...

ICH E11A Pediatric Extrapolation Guidance

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FDA publishes the International Council on Harmonization E11A Pediatric Extrapolation guidance.