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Gilead Ready To Go After Hepatitis D Again

 
• By Joseph Haas

Following an FDA complete response in 2022, Gilead is getting ready to refile bulevirtide for hepatitis D. The drug already is approved in the EU, UK and elsewhere.

Gilead
Gilead is getting ready to refile for US approval of bulevirtide in hep D • Source: Shutterstock: Tada Images

With new data presented at the recent European Association for the Study of the Liver meeting, Gilead is ready to seek US approval of its hepatitis D therapy bulevirtide once again.

Key Takeaways
  • Gilead plans to refile bulevirtide for FDA approval in hepatitis D about three years after a complete response letter citing manufacturing and delivery concerns.

The firm had been delayed in bringing what would be the first approved therapy for hepatitis D to market in...

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