FDA greenlights first home COVID test with traditional premarket review
By
Alicia Lasek
Jun 07, 2023
The Cue COVID-19 Molecular Test is the first at-home COVID-19 test to be granted marketing authorization outside of emergency use authorities, representing a new era of consumer access to diagnostic tests,...
Expect false positives: FDA letter to providers explains COVID antigen test results
By
Alicia Lasek
Nov 05, 2020
The agency clarifies that rapid antigen tests, “like all diagnostic tests,” are subject to false positive results, especially in low prevalence settings. It offers recommendations for administering...
Biogen seeks FDA approval for Alzheimer’s drug; aims to be first to slow disease
By
Alicia Lasek
Jul 09, 2020
Treatment with aducanumab reduced declines in memory, language, and activities of daily living performance, the drugmaker says.
FDA: Evusheld may be less effective against latest COVID variants
By
Alicia Lasek
Oct 05, 2022
Evusheld, a preventive COVID-19 antibody for high-risk patients, may lose efficacy in the face of newly emerging variants, the FDA has informed clinicians.
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.
Lawmakers push to keep ‘ineffective’ new opioids from market
By
Alicia Lasek
Mar 08, 2023
Congressional lawmakers have renewed efforts to give the Food and Drug Administration more power to deny drug applications for opioids that are not proven clinically superior to and lower risk than currently...
FDA proposes two annual COVID shots for seniors in ‘simplified’ vaccine schedule
By
Alicia Lasek
Jan 24, 2023
In an effort to streamline COVID-19 protection, older adults and others vulnerable to severe disease would receive two annual shots of an updated vaccine, according to a plan to be evaluated on Thursday...
Ambien alternative? FDA approves insomnia drug that improves sleep in seniors
By
Alicia Lasek
Jan 01, 2020
New insomnia medication lemborexant compared favorably to an extended release form of Ambien in a late-stage clinical trial.
On eve of Alzheimer’s drug decision, Congress critiques FDA for Aduhelm review failures
By
Alicia Lasek
Jan 03, 2023
An “atypical review process and corporate greed” factored into the FDA’s approval of Alzheimer’s drug Aduhelm in 2021, congressional investigators say. They recommend sticking to protocol...
First appropriate use guidance published for Alzheimer’s drug Aduhelm
By
Alicia Lasek
Jul 28, 2021
The new guidelines cover how to choose appropriate patients, safely scale up to a full dose, monitor side effects and assess effectiveness. The authors also address when to stop therapy and what patients...