FDA States Submission Date of Gilead’s Coronavirus Treatment Orphan Status Application is ‘Confidential’

On Monday March 23, 2020, Gilead Sciences’ remdesivir received orphan designation from the US Food and Drug Administration (FDA) for the treatment of COVID-19. Remdesivir has been reported to be one of the candidates to potentially treat COVID-19, which the… Continue Reading

FDA gives Gilead a seven year regulatory monopoly for remdesivir to treat COVID-19, on grounds it is an “Orphan” treating a rare disease

Today the FDA granted Gilead Orphan Drug status for remdesivir for the treatment of COVID-19, on grounds this is a rare disease. The morning of the designation, the U.S. had confirmed, through testing, more than 35 thousand cases, including 8,477… Continue Reading