COVID shots in the same arm may give better immunity … Mild cognitive impairment linked to weaker decision-making … Older women with Parkinson’s disease aren’t exercising enough … FDA approves...
FDA greenlights first home COVID test with traditional premarket review
By
Alicia Lasek
Jun 07, 2023
The Cue COVID-19 Molecular Test is the first at-home COVID-19 test to be granted marketing authorization outside of emergency use authorities, representing a new era of consumer access to diagnostic tests,...
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 approves pill to treat deadly C. difficile infections
By
Alicia Lasek
Apr 28, 2023
The first-of-its-kind fecal microbiota pill treats recurrent infections caused by Clostridium difficile, an antibiotic-resistant bacterium that’s a danger to nursing home residents.
Providers call for broader antipsychotic exclusions to help reduce schizophrenia diagnoses
By
Kimberly Marselas
Mar 31, 2023
Providers and quality experts are questioning why the agency hasn’t done more to review its quality measure for antipsychotic drug use.
FDA aims to expand the use of salt substitutes in processed foods
By
Alicia Lasek
Mar 28, 2023
The FDA wants to allow manufacturers of regulated, everyday foods to replace salt with “safe and suitable” substitutes.
FDA advisers support full approval of Paxlovid for at-risk older adults
By
Alicia Lasek
Mar 16, 2023
The antiviral drug Paxlovid should receive full FDA approval to treat COVID-19 in older adults at risk of severe outcomes, the advisers decided in a Thursday vote.
VHA to cover new Alzheimer’s drug Leqembi, despite CMS’s restraint
By
Alicia Lasek
Mar 14, 2023
The Veterans Health Administration will provide coverage for the recently approved drug lecanemab (Leqembi) to qualified veterans with early Alzheimer’s disease. It’s a surprise move considering...
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...
Lawmakers push to keep ‘ineffective’ new opioids from market
By
Alicia Lasek
Mar 08, 2023
Congressional lawmakers have renewed efforts to give the Food and Drug Administration more power to deny drug applications for opioids that are not proven clinically superior to and lower risk than currently...