May 14, 2024 03:21 PM EDT

Destruction of documents, insufficient data lead FDA to reject hep B vaccine update

Nicole DeFeudis

Editor

Dynavax’s hepatitis B vaccine was rejected for a label expansion in the US after patient data was destroyed by a third-party clinical trial site operator …

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Destruction of documents, insufficient data lead FDA to reject hep B vaccine update

Nicole DeFeudis

Editor

Sign up to read this article for free.

Applied Therapeutics' rare disease drug gets a CRL

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De­struc­tion of doc­u­ments, in­suf­fi­cient da­ta lead FDA to re­ject hep B vac­cine up­date

Nicole DeFeudis

Editor

Sign up to read this article for free.

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