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Another Study Needed for Iomab-B BLA: FDA

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FDA asks Actinium Pharmaceuticals for another Phase 3 study to support a BLA submission for Iomab-B in patients with active relaps...

Pentax Duodenoscope Cleared for New Reprocessing

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FDA clears a Pentax Medical 510(k) to acknowledge its DEC (Disposable Elevator Cap) Duodenoscopes compatibility with Advanced Ster...

Anesthetic/Analgesic Drugs Panel Renewed

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Federal Register notice: FDA announces the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee for an additio...

Inspires Sleep Apnea Neurostimulator Approved

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FDA approves Inspire Medical Systems Inspire V therapy system which includes the next generation neurostimulator for treating slee...

ICH Guides on Drug Interaction Studies

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Federal Register notice: FDA makes available a final guidance entitled M12 Drug Interaction Studies and the supplemental document ...

Gene Therapy for Synovia Sarcoma Approved

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FDA grants Adaptimmune an accelerated approval for its BLA for Tecelra (afamitresgene autoleucel), a gene therapy indicated for tr...

Orphan Status for Cellectis Leukemia Therapy

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FDA grants Cellectis an orphan drug designation for CLLS52 (alemtuzumab), an investigational therapy for treating relapsed/refract...

DePuy Robotic Knee Replacement Cleared

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FDA clears a DePuy Synthes 510(k) for its VELYS Robotic-Assisted Solution and its use in unicompartmental knee arthroplasty.

Octapharmas Fibryga OKs for Expanded Use

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FDA approves an Octapharma supplemental NDA for the expanded approval of Fibryga (fibrinogen) for fibrinogen replacement in bleedi...

Info Collection on Kratom Research Study

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Federal Register notice: FDA seeks comments on a proposed information collection entitled Risk/Safety Considerations and Motivatio...