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FDA Slow to Inspect Monkeypox Vaccine Facility: Article

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A New York Magazine investigative report says FDA is partly responsible for delays in getting sufficient monkeypox vaccine doses i...

Abbott Deep Brain Depression Device is Breakthrough Device

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FDA grants breakthrough device designation to the Abbott deep brain stimulation system for use in treatment-resistant depression.

FDA Clears Philips SmartSpeed Software

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FDA clears the Philips SmartSpeed MR acceleration software.

Citrus Plans I/ONTAK Lymphoma Drug BLA

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Citrus Pharmaceuticals says it will submit a BLA to FDA later this year for its I/ONTAK T-cell lymphoma treatment.

FDA Lifts Greenwich Flamingo-01 Trial Hold

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FDA lifts its clinical hold on a Greenwich LifeSciences Phase 3 trial of the companys invasive breast cancer investigational treat...

Catalyst Says Jacobus Patent Suit is Settled

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Catalyst says it has settled its patent litigation with Jacobus over Catalysts Firdapse and Jacobus Ruzurgi.

Comments Extended on Drug Shortages Guide

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Federal Register notice: FDA extends the comment period on a draft guidance entitled Risk Management Plans to Mitigate the Potenti...

Elite Supplement Center Illegally Selling SARM Products: FDA

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FDA warns Elite Supplement Center that it is illegally marketing selective androgen receptor modulator products that are legally c...

Byondis BLA for Breast Cancer Therapy Accepted

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FDA accepts for review a Byondis BLA for SYD985 ([vic-] trastuzumab duocarmazine) for use in patients with HER2-positive unresecta...

FDA Copiktra Warning About Higher Risk of Death

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FDA says clinical trial results show an increased risk of death and serious side effects associated with Secura Bios cancer drug C...