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FDA Downplays Impact After Pfizer Tornado

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FDA says it does not expect any immediate impact on drug supplies due to tornado damage at Pfizers Rocky Mount, NC sterile drug ma...

ICH Mutagenic Impurities Drug Guidance

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FDA posts an International Council for Harmonization-developed guidance entitled M7(R2) Assessment and Control of DNA Reactive (Mu...

FDA Spending Bill Will See Veto: White House

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The Biden Administration threatens to veto a House spending measure that includes cuts to FDAs budget.

Syndax/Incyte Plan BLA for Axatilimab

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Syndax Pharmaceuticals and Incyte plan to file by the end of the year a BLA for axatilimab, for use in adult and pediatric patient...

Horizon Misses on Lupus Phase 2 Endpoint

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Horizon Therapeutics says a Phase 2 clinical trial evaluating daxdilimab for treating systemic lupus erythematosus failed to meet ...

Nesa Medtech Fibroid Mapping App Cleared

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FDA clears a Nesa Medtech 510(k) for its Fibroid Mapping Reviewer Application (FMRA), intended for use by physicians to generate a...

FDA OKs Verrica NDA for Molluscum Topical

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FDA approves a Verrica Pharmaceuticals NDA for Ycanth (cantharidin) topical solution for treating molluscum contagiosum (molluscum...

Datascope Recalls Cardiosave IntraAortic Pumps

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Datascope recalls its Cardiosave Rescue IntraAortic Balloon Pumps because of the potential for an unexpected shutdown of the pump....

ADC Therapeutics Discontinues Phase 2 Trial

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ADC Therapeutics says it is discontinuing its Phase 2 LOTIS-9 clinical trial evaluating Zynlonta (loncastuximab tesirine-lpyl) and...

Bufferin NDA Withdrawn by FDA

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Federal Register notice: FDA withdraws approval of an NDA for Bufferin (aspirin) tablets because the application holder has failed...