Project PAUSE (Psychoactive Appropriate Use for Safety and Effectiveness) will hold a workshop exploring black box warnings on antipsychotic medication instructions, especially for older adults.
A first: FDA approves drug to treat agitation in Alzheimer’s dementia
By
Alicia Lasek
May 12, 2023
For the first time, the FDA has approved a drug to treat agitation related to Alzheimer’s disease dementia. Patient advocates are hailing the news, but prescribing the drug, an antipsychotic, may put...
FDA’s vaccines chief foresees deployment of another COVID-19 booster for older adults
Oct 25, 2022
This fall’s updated booster shot may not be the last one that older adults need this year, says the Food and Drug Administration’s Peter Marks.
Pfizer asks FDA to approve omicron-specific booster shot
Aug 22, 2022
The drug company says that its new mRNA vaccine produces an immune response against the BA.4 and BA.5 omicron subvariants.
FDA approves over-the-counter hearing aids, no exams required
By
Alicia Lasek
Aug 17, 2022
The Food and Drug Administration has established a new category of over-the-counter hearing aids that don’t require oversight by audiologists for purchase, according to a final rule announced Tuesday.
FDA advisers vote unanimously to endorse Novavax’s COVID-19 vaccine
By
Alicia Lasek (f3)
Jun 08, 2022
Independent advisers have voted 21 to 0 to recommend the authorization of Novavax’s COVID-19 protein-based vaccine for pandemic emergency use.
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.
COVID shot boosters for all adults will help to reduce confusion, FDA says
By
Alicia Lasek
Nov 22, 2021
The FDA “heard loud and clear” that a simpler booster strategy was needed, its vaccine chief says. But the action may be too late to head off a winter virus surge, observers say.
Merck to seek emergency use for COVID-19 antiviral pill that cuts severe outcomes by 50 percent
By
Alicia Lasek
Oct 04, 2021
Molnupiravir has reduced COVID-19 deaths and hospitalizations by half in a new clinical trial. An orally delivered drug could offer unprecedented treatment convenience, the drug’s developers say.
CDC chief endorses COVID booster shots for nursing home residents, healthcare workers
By
Alicia Lasek
Sep 24, 2021
Older and medically compromised adults and workers in high-risk settings should be offered third doses of the Pfizer-BioNTech vaccine, CDC Director Rochelle Walensky, M.D., said early Friday. Her decision...