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Gilead Misses on Trodelvy Confirmatory Study

[ Price : $8.95]

Gilead Sciences says it will be discussing with FDA a failed confirmatory study of accelerated-approval Trodelvy (sacituzumab govi...

FDA Raises Safety/Efficacy Issues with Lykos PTSD Drug

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An FDA advisory committee briefing document reveals reviewer concerns about safety and efficacy issues in a Lykos Therapeutics NDA...

Moderna RSV Vaccine Approved by FDA

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FDA approves a Moderna BLA for mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus vaccine for adults aged 60 years and older...

FDA Approves Next-Gen Recell Device

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FDA approves an Avita Medical PMA supplement for the Recell GO System, its next-generation autologous cell harvesting device.

Platform Tech Designation Program Guidance

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Federal Register notice: FDA makes available a draft guidance Platform Technology Designation Program for Drug Development.

NCTR Science Advisory Board Terminated

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Federal Register notice: FDA decides to terminate the Science Advisory Board to the National Center for Toxicological Research bec...

Scant Evidence for Accelerated Approval Markers: Study

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Researchers at Yale and Emory say they find little evidence to support the notion that surrogate markers used in non-oncologic dru...

FDA OKs Breyanzi in 4th Lymphoma Use

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FDA approves Bristol Myers Squibbs Breyanzi (lisocabtagene maraleucel; liso-cel) for treating adult patients with relapsed or refr...

Merck sBLA for Keytruda/Chemo in Mesothelioma

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FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) in combination with chemotherapy for the fir...

Defense-Friendly 5th Circuit Decision for Hospira

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Attorney James Beck says the 5th Circuit Court of Appeals made defense-friendly decisions in reversing several errors made by a Lo...