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Extended Review for Organons Vtama sNDA

[ Price : $8.95]

FDA extends by three months its review of an Organon supplemental NDA for Vtama (tapinarof) cream and its use for treating atopic ...

Objectionable Conditions at Hospital IRB

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FDA warns the Kittanning, PA-based Armstrong County Memorial Hospital IRB about objectionable conditions identified in a Bioresear...

FDA Cant Regulate AI on its Own: Califf

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FDA commissioner Robert Califf says collaboration with external stakeholders is needed to adequately monitor and regulate artifici...

Acadia Unloads Priority Voucher for $150 Million

[ Price : $8.95]

Acadia Pharmaceuticals sells its Rare Pediatric Disease Priority Review Voucher for $150 million.

FDA OKs Envoy Medical Cochlear Implant Study

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FDA approves an Envoy Medical IDE for its pivotal study of the Acclaim Fully Implanted Cochlear Implant.

CGMP Issues at Chinas Shandong Boyuan

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FDA issues an untitled letter to Chinas Shandong Boyuan Pharmaceutical Co. about CGMP deviations in its manufacturing of active ph...

Analytical Food Laboratories CGMP Violations

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FDA warns Grand Prairie, TX-based Analytical Food Laboratories about CGMP violations in its work as a drug contract testing labora...

FDA Clears SimBioSys TumorSight Expanded Use

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FDA clears a SimBioSys 510(k) for TumorSight Viz to expand its use by breast surgeons through artificial intelligence-based image ...

Merus Zeno BLA Gets 3 Month Review Extension

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FDA extends by three months its priority review of a Merus BLA for Zeno (zenocutuzumab) for treating patients with certain types o...

Support, Suggestions for FDA Rare Disease Hub

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Four rare disease stakeholders say they support an FDA plan to create a Rare Disease Innovation Hub and suggest its initial priori...