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ACLU Sues FDA for Records on Mifepristone Review

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The ACLU files a lawsuit seeking to force FDA to release documents related to its ongoing safety review of mifepristone.

FDA Approves New Safety Warning for Elevidys

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FDA says it is approving new labeling submitted by Sarepta Therapeutics for its gene therapy Elevidys (delandistrogene moxeparvove...

Parabilis FOG-001 Wins FDA Fast Track for Desmoid Tumors

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FDA grants Parabilis Medicines a fast track designation for FOG-001, a first-in-class inhibitor targeting the β-catenin:TCF i...

Gileads Single-Tablet HIV Regimen Meets Trial Endpoint

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Gilead Sciences says its investigational single-tablet regimen combining bictegravir and lenacapavir met its primary endpoint in a...

Outlook Therapeutics BLA Resubmitted for Wet AMD

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FDA accepts for review an Outlook Therapeutics BLA resubmission for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic for...

FDA, HHS Cuts Can Hurt Trial Oversight: Caplan

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Medical ethicist Arthur Caplan voices concerns about human subject protection in clinical trials due to significant staff cuts at ...

Order Wells Pharma Indomethacin Off Market: Petition

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A Wiley Rein petition filed for a client asks FDA to order the immediate withdrawal of Wells Pharmas compounded 100 mg indomethaci...

FDA Approves First Interchangeable Perjeta Biosimilar

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FDA approves Shanghai Henlius Biologics Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Genentechs Perjeta (per...

Oversight of Influencer Social Media Posts Hard: Researchers

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University of Chicago researchers explain how difficult it will be to improve government oversight over social media influencer pr...

FDA Qualifies GLDH Biomarker

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FDA qualifies glutamate hydrogenase as a biomarker to enhance liver safety monitoring in clinical trials.