FDA has announced that it has signed off on the use of COVID-19 therapy Veklury (remdesivir) from Gilead Sciences (Nasdaq:GILD) to include children at least 28 days old who weigh at least 3 kg (roughly 7 lb) and test positive results for COVID-19. The indication is limited to children who are either hospitalized or have…
FDA extends approval of remdesivir to encompass non-hospitalized high-risk
Gilead Sciences’ (NSDQ:GILD) Veklury (remdesivir) became the first FDA-approved COVID-19 drug when it was approved in October 2020. Now, the company has announced that the FDA has granted expedited approval of a supplemental new drug application (sNDA) for the drug to treat non-hospitalized adult and adolescent patients with a high risk of progression to severe…
34 of the most innovative pharmaceutical products
The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to…
Remdesivir — a new blockbuster
In one sense, Veklury (remdesivir) is not a new drug. Gilead Sciences initially developed remdesivir (GS-5734) in reaction to the 2014 Ebola outbreak. The drug remained investigational, however, until the COVID-19 pandemic. In 2020, it became the first FDA-approved drug to treat COVID-19. Last year, it raked in $2.811 billion in revenue.
Questions dog Gilead’s COVID-19 drug remdesivir after FDA approval
Biotech firm Gilead Sciences is on the defensive as its revenue surges thanks to the COVID-19 drug Veklury, better known as remdesivir. Several press outlets are skeptical of the promise of remdesivir, the first COVID-19 treatment to win FDA approval. This week, Healthline questioned whether FDA should have approved the drug. The New York Times…