Biomarin's previously rejected hemophilia drug gets special status at the FDA

The FDA in the US has given Biomarin's gene therapy against hemophilia special status, which will speed up the approval process. The treatment was rejected in August last year.
Photo: Manuel Balce Ceneta/AP/Ritzau Scanpix
Photo: Manuel Balce Ceneta/AP/Ritzau Scanpix

When Biomarin again tries to get the US Food and Drug Administration (FDA) to approve the hemophilia treatment valoctocogene roxaparvovec, it'll get some help along the way.

Already a subscriber?Log in here

Read the whole article

Get access for 14 days for free. No credit card is needed, and you will not be automatically signed up for a paid subscription after the free trial.

With your free trial you get:

  • Access all locked articles
  • Receive our daily newsletters
  • Access our app
Must be at least 8 characters, including three of: Uppercase, lowercase, numbers, symbols
Must contain at least 2 characters
Must contain at least 2 characters

Get full access for you and your coworkers

Start a free company trial today

Share article

Sign up for our newsletter

Stay ahead of development by receiving our newsletter on the latest sector knowledge.

Newsletter terms

Front page now

Further reading