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Astellas Eye Drug Approved by FDA

[ Price : $8.95]

FDA approves an Astellas Pharmas Izervay (avacincaptad pegol intravitreal solution) for treating geographic atrophy secondary to a...

FDA Clears Abbotts Hematology Device

[ Price : $8.95]

FDA clears an Abbott 510(k)for its Alinity h-series hematology system for use by laboratories to run complete blood counts.

Cubicin Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Cubist Pharmaceuticals Cubicin and Cubicin RF (daptomycin) powder for injection were ...

Comments Sought on 8 Drugs for WHO Scheduling

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Federal Register notice: FDA seeks comments concerning abuse potential and the impact of scheduling changes on availability for me...

Guide on Nitrosamine Acceptable Intake Limits

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Federal Register notice: FDA makes available a final guidance entitled Recommended Acceptable Intake Limits for Nitrosamine Drug S...

Drger Recalls Carina Ventilators

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Drgerwerk recalls its Drger Carina Sub-Acute Care Ventilators due to the potential for contamination of the breathing gas.

Orphan Status for BRAF Inhibitor

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FDA grants ABM Therapeutics an orphan drug designation for ABM-1310, a novel small molecule BRAF inhibitor for treating patients w...

Mesoblast Sent Another Complete Response Letter

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FDA sends Mesoblast a second complete response letter on its BLA for remestemcel-L for treating pediatric steroid-refractory acute...

Biosense Webster New Label on Cardiac Ablators

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FDA approves new labeling to permit several Biosense Webster cardiac ablation devices to be used without relying on a fluoroscopy ...

Guide on Drug Supply Chain Security

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Federal Register notice: FDA makes available a final guidance entitled Waivers, Exceptions, and Exemptions from the Requirements o...