- The FDA's website indicates that it has fully approval Gilead Sciences' (GILD +0.8%) Veklury (remdesivir). It does not specify the specific indication, but the company completed its rolling application in early August for severely ill hospitalized COVID-19 patients.
- The agency granted emergency use authorization (EUA) for these patients on May 1.
- Update: The nod is for adults and pediatric patients at least 12 years old and weighing at least 40 kg with COVID-19 requiring hospitalization.
- The FDA has also issued a new EUA for Veklury for hospitalized pediatric patients under 12 years of age and weighing at least 3.5 kg or hospitalized pediatric patients weighing 3.5 kg to less than 40 kg with suspected or laboratory confirmed COVID-19 for whom the use of an intravenous agent is clinically appropriate.
- https://seekingalpha.com/news/3625009-fda-oks-gileads-remdesivir
Search This Blog
Thursday, October 22, 2020
FDA OKs Gilead's remdesivir
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.