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,...
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.
Moderna’s vaccine highly effective against COVID-19: FDA review
By
John O'Connor
Dec 16, 2020
Moderna’s COVID-19 vaccine is 94% effective in preventing symptomatic illness, according to information released Tuesday. The initial review’s findings appear to set the table for federal authorization...
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...
Vaccinated long-term care residents in the clear from COVID-19 — for now
By
Danielle Brown
Jul 12, 2021
Long-term care residents and staff fully vaccinated against COVID-19 don’t need booster shots anytime soon, according to federal health officials.
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...
FDA warns of heart-related events for arthritis drug Xeljanz and others in its class
By
Alicia Lasek
Sep 02, 2021
The agency is requiring a warning label on the arthritis and ulcerative colitis drugs Xeljanz and Xeljanz XR (tofacitinib) and two other drugs in this class, citing an increased risk of adverse health...
Clinical Daily Briefs for Thursday, March 26
By
Alicia Lasek
Mar 25, 2020
Argentum, AHCA / NCAL launch campaigns to share positive messages during pandemic … Clinic study shows where surface-cleaning efforts can fall short … CVS moves to prevent hoarding of malaria drug...