FDA Gives BioMarin Pharmaceuticals' Hemophilia Gene Therapy Priority Review

Submitted by admin on February 20, 2020 - 11:41pm

Source:

Motley Fool

News Tags:

FDA

Biomarin

priority review

valrox

gene therapy

hemophilia A

Headline:

FDA Gives BioMarin Pharmaceuticals' Hemophilia Gene Therapy Priority Review

snippet:

The Food and Drug Administration (FDA) has given BioMarin Pharmaceutical (NASDAQ: BMRN) a priority review for its valoctocogene roxaparvovec (valrox) gene therapy to treat patients with hemophilia A. The priority review will shave four months off of the review time for the marketing application, compared to a standard review. The agency expects to make a decision by Aug. 21, 2020.

Search form

You are here

FDA Gives BioMarin Pharmaceuticals' Hemophilia Gene Therapy Priority Review

FDA Gives BioMarin Pharmaceuticals' Hemophilia Gene Therapy Priority Review