FDA advisers endorse bivalent vaccine for all COVID mRNA shots
By
Alicia Lasek
Jan 27, 2023
A panel of experts on Thursday agreed that the bivalent COVID-19 vaccines should be used as both initial and booster shots, phasing out the original vaccines.
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...
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...
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.
FDA authorizes omicron-targeting vaccines as preferred COVID booster shots
By
Alicia Lasek
Sep 01, 2022
The FDA has authorized new, bivalent versions of Pfizer’s and Moderna’s COVID-19 vaccines to be used as booster shots. At the same time, the original monovalent versions are no longer authorized as...
Vaccine to protect seniors from RSV ready for FDA review, drugmaker says
By
Alicia Lasek (f3)
Jun 13, 2022
A vaccine to help prevent a leading cause of pneumonia in the elderly has been found effective in late-stage clinical trials.
New FDA initiative seeks to boost clinicians’ dietary supplements knowledge
By
Alicia Lasek (f3)
Jun 03, 2022
Educational supports for healthcare providers include a continuing education program on the benefits and risks of dietary supplements.
Lawmakers push FDA to take swift action on OTC hearing aids
By
Diane Eastabrook
Apr 12, 2022
A bipartisan team has introduced a bill that orders the FDA to stop dragging its feet and issue a final rule making over-the-counter hearing aids available to consumers.
U.S. COVID-19 strategy must veer to protecting the vulnerable, experts say
By
Alicia Lasek
Mar 22, 2022
When planning for a future with COVID-19, some clinicians believe that the public health focus should turn from stopping transmission to protecting those most likely to become severely ill, according to...
Novavax applies for FDA authorization of its protein-based COVID shot
By
Amy Novotney
Feb 02, 2022
Biotech firm Novavax disclosed Monday that it had submitted its long-awaited application to the U.S. Food and Drug Administration for an emergency use authorization for its COVID-19 vaccine in the United...