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FDA Probing Childrens Deaths from Covid Vaccine: Makary

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FDA commissioner Marty Makary says an evaluation of reports contained in the agencys vaccines adverse event database shows there h...

Positive Data on New Breast Cancer Drug

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BioNTech and Duality Biologics report that trastuzumab pamirtecan met its primary endpoint in a pivotal Phase 3 trial for patients...

Pyrukynd sNDA Extended Due to REMS Review

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FDA extends by three months its review of Agios Pharmaceuticals supplemental NDA seeking to expand the use of Pyrukynd (mitapivat)...

FDA Says Lillys Olomorasib is Breakthrough Therapy

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FDA grants breakthrough therapy designation to Lillys oloromasib for certain lung cancers.

14 GenoGenix Inspection Observations

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FDA releases the form FDA-483 containing 14 observations from an inspection at the GenoGenix outsourcing facility in Boca Raton, F...

Sanofi Dermatitis Drug Meets Endpoints in Study

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Sanofi says its investigational antibody amlitelimab met all primary and key secondary endpoints in a late-stage trial of patients...

RFK Jr. Grilled at Heated Senate Hearing

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Bipartisan criticism of Health and Human Services secretary Robert F. Kennedy Jr. dominates a contentious three-hour Senate Financ...

No Committee for Aquestives Anaphylm

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FDA says an advisory committee is not needed to discuss the Aquestive NDA for Anaphylm to treat severe allergic reactions.

FDA Pledges Prompt CRL Release

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FDA releases 89 previously unpublished complete response letters and says future letters will be released immediately after transm...

Medtronic Recalls DLP Left Heart Vent Catheters

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Medtronic Perfusion Systems recalls (Class 1) its DLP Left Heart Vent Catheters (malleable body and vented connector) because the ...