Biomarin resubmits rejected hemophilia medicine in US

The FDA will now have to consider whether new long-term data is sufficient to market authorize Biomarin’s gene therapy, a potential challenger to Novo Nordisk’s bleeding disorder treatments.

Photo: Manuel Balce Ceneta/AP/Ritzau Scanpix

Just as it said it would, Biomarin has now again submitted gene therapy valoctocogene roxaparvovec, a treatment for hemophilia A, for review by the US Food and Drug Administration (FDA), a company press release announces.

Already a subscriber? Log in.

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.

  • Access all locked articles
  • Receive our daily newsletters
  • Access our app
An error has occured. Please try again later.

Get full access for you and your coworkers.

Start a free company trial today

More from MedWatch

Bank believes in cancer approval for Genmab

In Jyske Bank’s eyes, Genmab’s newest cancer candidate is almost certain to be approved, though the bank says stock increases in the past year have reduced the upside potential for the Danish biotech firm.

Further reading

Related articles

Latest news

See all jobs