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

Zolgensma

Zolgensma is a gene therapy for spinal muscular atrophy (SMA) that was approved by the US FDA in May 2019, at a price of $2.1 million per patient. Zolgensma was licensed from a children’s hospital where it was developed on… Continue Reading