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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...

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FDA releases 89 previously unpublished complete response letters and says future letters will be released immediately after transm...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

FDA Posts Alopecia Complex Case Study

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FDA posts a drug complex innovative design case study for a higher dose of an alopecia areata drug that did not assign participant...

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.

CGMP Violations at Amneal Gujarat, India

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FDA warns Amneal Pharmaceuticals about CGMP violations in its Gujarat, India, drug manufacturing facility.

FDA, CDC Staff Pen Open Letter to Remove RFK Jr.

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Over a thousand current and former staff at FDA, CDC, and NIH pen a new open letter to HHS secretary Robert F. Kennedy Jr. and Con...