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.
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.
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.
FDA OKs third antibody COVID therapy; variants spur new pause on another
By
Alicia Lasek
Jun 01, 2021
A new COVID-19 treatment made by GlaxoSmithKline now is the third monoclonal antibody therapy federally authorized to help prevent severe disease outcomes in high-risk patients. But gene variants are interfering...
FDA calls for investigation into its approval of controversial Alzheimer’s drug
By
Alicia Lasek
Jul 12, 2021
The acting chief of the Food and Drug Administration has called for an investigation into the events leading up to the approval of Biogen’s brain plaque-clearing dementia drug aducanumab (Aduhelm).
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...
CDC briefing: Top officials talk up vaccine plans, focus on long-term care
By
Alicia Lasek
Oct 22, 2020
Federal health officials touted transparency and nationwide distribution plans while keeping their eye on Phase 1 vaccine recipients, including LTC residents and workers.
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...
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.