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Closer Drug Postapproval Monitoring Needed: Researchers

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Harvard Medical School researchers say FDA should clearly indicate when it has extrapolated an approved drug indication from pivot...

No CDER Objection to Covis Materials for Makena Hearing

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CDER says it doesnt object to additional materials Covis Pharma wants to introduce at a hearing on the FDA proposal to withdraw ap...

False Results in Some Prenatal Screening Tests

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FDA cautions that noninvasive prenatal screening tests can give false results that can lead to inappropriate decisions without a c...

PI3K Briefing Document Reiterates FDA Concerns

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FDA reiterates concerns with phosphatidylinositol 3-kinase (PI3K) inhibitors and their approval for treating hematological maligna...

FDA Debars Clinical Investigator

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Federal Register notice: FDA permanently debars Yvelice Villaman-Bencosme from providing services in any capacity to a person that...

FDA Revokes 5 Covid Test EUAs

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Federal Register notice: FDA is revoking the emergency use authorizations on five no-longer-marketed Covid-19 tests.

Pazdur et al Weigh Challenges with PI3K Inhibitors

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Writing in an online Lancet Oncology article, FDA officials outline challenges with current PI3K inhibitors that have the agency r...

Diversity Plans Needed Before Phase 3: Law Firm

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A Hogan Lovells analysis of FDAs recent guidance on clinical trial diversity plans says such plans should be an important part of ...

Nektar, BMS Nix Opdivo/Bempegaldesleukin Trials

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Nektar Therapeutics and Bristol Myers Squibb end their clinical development program for bempegaldesleukin in combination with Opdi...

Ukoniq Withdrawn Due to Overall Survival Concerns

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Due to overall survival concerns, TG Therapeutics withdraws its accelerated approval of Ukoniq (umbralisib), a PI3K inhibitor for ...