Biogen launches new trial of Alzheimer’s drug aducanumab
By
Alicia Lasek
Apr 29, 2021
The new trial, called EMBARK, will re-dose patients who took part in the drug’s earlier clinical studies. It is expected to be one of the largest clinical trials in Alzheimer’s disease, the company...
Long-term care holds its breath after feds unpause J&J COVID vaccine
By
Danielle Brown
Apr 26, 2021
Long-term care pharmacies can begin immediately using Johnson & Johnson’s COVID-19 vaccine again after the Centers for Disease Control and Prevention and Food and Drug Administration lifted a pause on...
Feds look to OTC drugs for self-treatment of mild, moderate COVID
By
Alicia Lasek
Apr 21, 2021
A large trial is set to study the potential for repurposed, over-the-counter drugs to treat mild-to-moderate COVID-19 symptoms. If found effective, the approval timeline will likely be short, according...
While FDA moves to halt mask reuse, N95 access remains spotty, report finds
By
Alicia Lasek
Apr 15, 2021
A new push to ensure that healthcare facilities stockpile single-use or reusable N95 respirators has arrived while some workers continue to lack access to the equipment and U.S. mask manufacturers can’t...
FDA says it’s time to move away from mask reuse
By
Alicia Lasek
Apr 13, 2021
Healthcare facilities should move away from decontaminating and reusing disposable masks now that U.S. respirator supply has recovered, the agency says.
FDA advisers object to Alzheimer’s drug aducanumab ahead of final decision
By
Alicia Lasek
Apr 05, 2021
The experimental Alzheimer’s drug aducanumab is not ready for federal approval in June, advisers to the Food and Drug Administration say in a new JAMA editorial.
No more reading glasses? Eye drop for seniors’ vision loss lands on FDA’s desk
By
Alicia Lasek
Mar 09, 2021
Drugmaker Allergan is seeking federal approval for a new eye drop that treats presbyopia, the common age-related vision loss that often prompts a need for reading glasses.
Feds approve one-dose Johnson & Johnson vaccine for emergency use
By
Alicia Lasek
Mar 01, 2021
The drug is 67% effective against COVID-19 by two weeks after vaccination, and 100% effective in protecting against hospitalization, ICU admission and death, an FDA advisory panel member emphasized.
J&J coronavirus shot nears U.S. approval with 66% efficacy, but data on elders limited
By
Alicia Lasek
Feb 25, 2021
There were no COVID-19-related deaths or cases requiring medical intervention four weeks or more after vaccination in adults age 60 and older. But there were not enough participants aged 75 and older to...
Nurses union to FDA: Mask decontamination never should have been OK’d
By
Alicia Lasek
Jan 29, 2021
The reuse of N95 respirators and other single-use PPE is unsafe, according to the lead hygienist of National Nurses United. The union is heartened by President Joe Biden’s promise to use the Defense...