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BMS, J&J Halt Phase 3 Librexia Trial After Futility Review

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Bristol Myers Squibb (BMS) and Johnson & Johnson stop their Phase 3 Librexia ACS trial of the investigational anticoagulant milvex...

FDA Previews Reforms as Pazdur Takes Over CDER

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FDA commissioner Marty Makary and CBER director Vinay Prasad preview upcoming agency reforms during an FDA Direct podcast focused ...

Rising Concerns Over FDA Consistency, Transparency: Axios

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An Axios report examines growing criticism of recent FDA actions that are fueling uncertainty among drug developers and weakening ...

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...

Guide on PH Waivers for Certain Generics

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FDA posts a final guidance entitled Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Pare...

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...