Y-mabs resubmits cancer drug for marketing approval in the US

After several years’ delay, Y-mabs has now filed another marketing application for cancer drug candidate with the US health authority after the first was rejected in 2020.

Photo: Kelly Davidson Photography

Danish-American biotech firm Y-mabs has announced it has resubmitted a Biologics License Application (BLA) for its delayed cancer drug candidate, omburtamab, with the US health authority, according to a company press release on Thursday last week.

The Food and Drug Administration (FDA) rejected the company’s first approval attempt back in October 2020, saying it wanted more data for the drug candidate, which is designed to treat children with the cancer type known as neuroblastoma.

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

Further reading

Related articles

Latest news

See all jobs