FDA authorizes remdesivir for certain non-hospitalized patients, new at-home test for COVID-19

Jan 24, 2022 - 02:10 PM
FDA product update

The Food and Drug Administration Friday expanded the approved uses for Vekury (remdesivir) to include non-hospitalized patients aged 12 and older who test positive for SARS-CoV-2, weigh at least 88 pounds and are at high risk of progressing to severe COVID-19. The agency also authorized emergency use of the drug for high-risk, non-hospitalized pediatric patients who weigh less than 88 but more than 8 pounds, including patients under age 12. The drug previously was limited to hospitalized patients. The expanded uses are based on results from a clinical trial that showed the drug reduced hospitalizations in high-risk, non-hospitalized patients. For more information, see the updated provider and patient fact sheets.

In other news, the FDA last week issued an emergency use authorization for another over-the-counter COVID-19 test. It said the MaximBio ClearDetect COVID-19 Antigen Home Test delivers results in 15 minutes.

 

Related News Articles

Headline
CDC adopts ACIP recommendations for COVID-19, chickenpox vaccines
The Centers for Disease Control and Prevention will update its immunization schedules for the COVID-19 and chickenpox vaccines to adopt recent recommendations…
Headline
FDA seeks feedback on measuring AI-enabled medical device performance
The Food and Drug Administration today issued a request for public comment on a series of questions regarding current approaches to evaluating artificial…
Headline
Olympus recalls endoscope needles
The Food and Drug Administration yesterday announced that Olympus issued a global recall of its ViziShot 2 FLEX needles manufactured prior to May 12 following…
Headline
ACIP recommends patients consult their provider for COVID-19 vaccine
The Advisory Committee on Immunization Practices Sept. 19 recommended that patients should consult their health care provider if they want to receive a COVID-…
Headline
FDA issues serious recall for electric wheelchair joysticks
The Food and Drug Administration has identified a Class I recall for Mo-Vis BVBA R-net Joysticks due to a firmware error that causes the wheelchair to ignore…
Headline
CDC says COVID-19 cases growing or likely growing in 45 states 
COVID-19 infections are growing or likely growing in 45 states and not changing in five states, according to the latest data from the Centers for Disease…