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Amgens Blincyto Gets Expanded Leukemia Use

[ Price : $8.95]

FDA approves an expanded use for Amgens Blincyto (blinatumomab) for treating adult and pediatric patients one month or older with ...

3 Bayesian Examples Added to Demonstration Project

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FDA adds three Bayesian statistical analysis examples to the CDER Center for Clinical Trial Innovation Web page.

Supreme Court Rejects Mifepristone Lawsuit

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The U.S. Supreme Court 6/13 unanimously rejects a lawsuit seeking to sharply restrict distribution of the chemical abortion pill m...

FDA Revises Covid Vaccine Composition Recommendation

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FDA updates its advice on this falls Covid-19 vaccine composition based on a recent review of circulating Covid cases in the U.S.

Pfizer Duchene Gene Therapy Fails Phase 3 Study

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Pfizer says that its Phase 3 CIFFREO placebo-controlled study evaluating an investigational mini-dystrophin gene therapy, fordadis...

Shaver Permanently Debarred by FDA

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Federal Register notice: FDA issues an order permanently debarring Jonathan R. Shaver from providing services in any capacity to a...

FDA Debars Smith for 5 Years

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Federal Register notice: FDA issues an order debarring Richard B. Smith III for five years from importing or offering for import a...

Emerging Drug Safety Technology Meeting Program

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CDER Office of Surveillance and Epidemiology deputy director Robert Ball describes the Emerging Drug Safety Technology Meeting pro...

DSCSA Pilot Project Report Out

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FDA says it has issued a final report from the Drug Supply Chain Security Act pilot project.

ICH M10 Bioanalytical Method Analysis Q&A Guidance

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FDA publishes an International Council for Harmonization question-and-answer guidance responding to questions about its M10 bioana...