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Atrovent Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Boehringer Ingelheim Pharmaceuticals Atrovent (ipratropium bromide) metered spray 0.0...

FDA Approves Biogens Alzheimers Drug

[ Price : $8.95]

FDA grants accelerated approval for Biogens Aduhelm (aducanumab), the first drug since 2003 approved for treating Alzheimers.

Medtronic Deep Brain Stimulator Lead Approved

[ Price : $8.95]

FDA approves a Medtronic PMA for the SenSight Directional Lead System used for deep brain stimulation therapy.

Ultomiris OKd for Pediatric Blood Disorder

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FDA approves an Alexion Pharmaceuticals BLA for Ultomiris (ravulizumab-cwvz) injection and its use in treating patients aged one m...

FDA Lifts Holds on Bluebird Bio Trials

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FDA lifts clinical holds against Bluebird Bios Phase 1/2 (HGB-206) and Phase 3 (HGB-210) studies of LentiGlobin gene therapy for s...

ProMetics Ryplazim Approved for Plasminogen Disorder

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FDA approves a ProMetic Biotherapeutics BLA for Ryplazim (plasminogen, human-tmvh) for treating patients with plasminogen deficien...

Guide on Suspect/Illegitimate Product Definitions

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Federal Register notice: FDA posts a draft guidance on drug supply chain definitions of suspect and illegitimate products.

Guide on Drug Supply Security Product Identifiers

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Federal Register notice: FDA makes available a final guidance entitled Product Identifiers Under the Drug Supply Chain Security Ac...

Supply Chain Security Act Implementation Guide

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Federal Register notice: FDA makes available a final guide entitled Drug Supply Chain Security Act Implementation: Identification ...

Drug Distribution Security at Package Level Guide

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Federal Register notice: FDA makes available a draft guidance discussing enhanced drug distribution security at the package level....