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Keyword: orphanstatus

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  • Gilead asks FDA to take back lucrative orphan drug status on possible coronavirus treatment - Remdesivir

    03/26/2020 8:04:17 AM PDT · by SeekAndFind · 3 replies
    Reuters ^ | 03/26/2020 | Manas Mishra, Michael Erman
    Gilead Sciences Inc on Wednesday took the unusual step of asking the U.S. Food and Drug Administration to rescind a controversial orphan drug designation the agency had granted for the biotech company’s potential coronavirus treatment remdesivir just 48 hours earlier. The FDA agreed to the withdrawal, and said it is actively working to speed development of medical products desperately needed to prevent or treat the highly contagious COVID-19 illness caused by the virus. Shares of the California-based company closed down nearly 6% at $69.66. The company was criticized by lawmakers and patient advocates after receiving the orphan designation on Monday...