Results are available in about 20 minutes via a mobile phone app, and the test is more than 90% accurate in both symptomatic and asymptomatic individuals, the agency announced Tuesday.
FDA may grant Pfizer vaccine full approval by Labor Day: report
By
Alicia Lasek
Aug 05, 2021
The nationwide rise in COVID-19 cases driven by the highly transmissible delta strain has spurred the agency move quickly, sources told The New York Times.
Clinical Briefs for Wednesday, Nov. 6
By
Alicia Lasek
Nov 05, 2019
Single odds-defying case may lead to new Alzheimer’s treatments … Fully digital Alzheimer’s study to track risk factors in 400,000 volunteers … Blood samples may identify those at risk for frailty...
Clinical briefs for Friday, Oct. 23
By
Alicia Lasek
Oct 23, 2020
Remdesivir becomes first fully FDA-approved COVID-19 treatment in U.S. … Soy consumption may decrease key risk factor for dementia … COVID mortality rate widening between U.S. and peer countries …...
COVID shot boosters for all adults will help to reduce confusion, FDA says
By
Alicia Lasek
Nov 22, 2021
The FDA “heard loud and clear” that a simpler booster strategy was needed, its vaccine chief says. But the action may be too late to head off a winter virus surge, observers say.
Promising antidepressant fails in late-stage trial
By
Alicia Lasek
Dec 05, 2019
Fast-tracked antidepressant Sage-217 failed to outperform a placebo in a stage 3 trial, according to its developer.
FDA halts use of REGEN-COV, Eli Lilly monoclonal antibodies
By
Alicia Lasek
Jan 26, 2022
The Food and Drug Administration has revoked its emergency use authorizations for two monoclonal antibody cocktails that have served as COVID-19 treatment mainstays in long-term care facilities.
FDA expands use of remdesivir to skilled nursing, other non-hospital settings
By
Alicia Lasek
Jan 25, 2022
Remdesivir, the first FDA-approved COVID-19 drug, now can be used in adult and pediatric patients with mild-to moderate COVID-19 illness at high risk of progressing to severe disease, the agency has announced.
FDA authorizes monoclonal antibody that tackles omicron
By
Alicia Lasek
Feb 15, 2022
Bebtelovimab is greenlit for treatment of mild to moderate COVID-19 in patients at high risk of severe disease. The move comes amid a federal push to increase supply of effective therapies.
FDA greenlights Novavax’s COVID-19 vaccine, adding unique option to U.S. arsenal
By
Alicia Lasek (f3)
Jul 14, 2022
The FDA late Wednesday authorized Novavax’s adjuvanted COVID-19 vaccine for emergency use in adults aged 18 years and older.