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Panel to Discuss Sickle Cell Therapy

[ Price : $8.95]

Federal Register notice: FDA announces a 10/31 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to review a Vertex ...

3 New 510(k) Guidances

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FDA posts an update on changes being made to the 510(k) program through three draft guidances.

Positron Emission Tomography Meeting Set

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The FDA Office of New Drugs announces a two-day meeting on PET drug issues and concerns.

Rybrevant Hits Phase 3 Goals in Some Lung Cancers

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Janssen says its Rybrevant met its progression-free survival endpoint in the MARIPOSA-2 lung cancer trial.

FDA Denies ICAN Pertussis Labeling Petition

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FDA denies an ICAN petition asking for changes to labeling for acellular pertussis vaccines to say they do not prevent infection o...

Complete Response Letter on Ultomiris sBLA

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FDA issues Alexion a complete response letter on a supplemental BLA for long-acting C5 complement inhibitor Ultomiris and its use ...

Guide on Drug Supply Chain Security

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Federal Register notice: FDA makes available a final guidance entitled DSCSA Standards for the Interoperable Exchange of Informati...

FDA OKs Boston Scientifics Watchman FLX Pro

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FDA approves Boston Scientifics latest generation of its Watchman FLX Pro Left Atrial Appendage Closure device.

Strong Response in New Moderna Covid Vaccine

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Moderna says its updated Covid-19 vaccine demonstrated a strong response against the new BA.2.86 variant that is being closely wat...

FDA, Flatiron Health Real-world Data Pact

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FDAs Oncology Center of Excellence and Flatiron Health renew a five-year collaboration to jointly develop and implement specific r...