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.
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.
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.
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.
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...
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 OKs new insulin biosimilar for type 2 diabetes
By
Alicia Lasek
Jul 30, 2021
Semglee is a safe and more cost-effective alternative to the drug Lantus (insulin glargine), the agency announced Wednesday. Semglee does not need a prescriber’s input to be substituted at the pharmacy.