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.
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’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 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.
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...
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...