FDA advisers vote ‘no’ on drug that may slow Alzheimer’s progression
By
Alicia Lasek
Nov 09, 2020
If approved by the FDA, aducanumab would be the first-ever drug marketed to slow progression of the brain-wasting disease, according to its developer. But an advisory committee was unconvinced of the drug’s...
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 advisers recommend Moderna COVID booster for seniors, others at high risk
By
Alicia Lasek
Oct 15, 2021
In a unanimous vote, advisers agreed that vulnerable Moderna vaccine recipients should be offered a third shot. A half dose will be effective and will help protect against side effects, the drugmaker says.
FDA approves $5 rapid-results COVID antigen test
By
Alicia Lasek
Aug 28, 2020
The test involves a credit-card-sized device that functions like some pregnancy tests. The developer expects to begin shipping large quantities in September.
FDA moves to discard hearing aid prescription rule in favor of OTC devices
By
Alicia Lasek
Oct 20, 2021
Adults with mild to moderate hearing loss would be able to obtain certain air-conduction hearing aids without a prescription under a new proposed rule. Whether this change would benefit long-term care...
COVID trial vaccines may be inadequate, some FDA advisors fear
By
Alicia Lasek
Oct 26, 2020
The current vaccine trials may be too focused on mild rather than severe disease, some advisors contend. But their arguments got pushback in a meeting streamed on the agency’s YouTube channel.
Drug that targets Alzheimer’s inflammation approved for trial by FDA
By
Alicia Lasek
Feb 09, 2021
An experimental drug meant to treat the “type 3 diabetes” that some scientists believe triggers Alzheimer’s has been approved for a late-stage clinical trial.
Feds gauging threat to vaccine, test and treatment efficacy in face of omicron variant
By
Alicia Lasek
Dec 01, 2021
The United States is prepared to address any potential threat to the effectiveness of COVID-19 vaccines, tests and treatments posed by the new variant, according to the White House and federal health officials.
Masks arrive from ‘dubious’ sources, bearing false FDA certificates: report
By
Alicia Lasek
Jul 21, 2020
In a rush to meet demand for face masks and respirators, some manufacturers have turned out poor quality products while claiming federal approval, according to a new report.
FDA to withdraw certain drug-related guidances with end of PHE
By
Alicia Lasek
Mar 14, 2023
The Food and Drug Administration has issued a notice detailing which COVID-19-related guidances will expire when the public health emergency ends as scheduled on May 11, and which guidances will remain...