FDA approves second monoclonal antibody treatment for early Alzheimer’s disease
By
Kristen Fischer
Jul 02, 2024
The US Food and Drug Administration (FDA) approved a second monoclonal antibody treatment for for early Alzheimer’s on Tuesday. Eli Lilly’s Kisunla (donanemab), which has proven to slow the disease...
Clinical briefs for Thursday, May 16
By
Kristen Fischer
May 15, 2024
Study: Sleep apnea severity linked to verbal memory decline … Test ties mobility to cognitive function … Spotting osteosarcopenia in heart valve operation patients could predict post-surgical death...
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,...
FDA: Evusheld may be less effective against latest COVID variants
By
Alicia Lasek
Oct 05, 2022
Evusheld, a preventive COVID-19 antibody for high-risk patients, may lose efficacy in the face of newly emerging variants, the FDA has informed clinicians.
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...
FDA proposes two annual COVID shots for seniors in ‘simplified’ vaccine schedule
By
Alicia Lasek
Jan 24, 2023
In an effort to streamline COVID-19 protection, older adults and others vulnerable to severe disease would receive two annual shots of an updated vaccine, according to a plan to be evaluated on Thursday...
On eve of Alzheimer’s drug decision, Congress critiques FDA for Aduhelm review failures
By
Alicia Lasek
Jan 03, 2023
An “atypical review process and corporate greed” factored into the FDA’s approval of Alzheimer’s drug Aduhelm in 2021, congressional investigators say. They recommend sticking to protocol...
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.
Clinical briefs for Tuesday, Oct. 3
By
Kristen Fischer
Oct 03, 2023
WHO: Switch back to trivalent flu shots … Vascular cells needed to form long-term memories … Radiation could treat inoperable kidney tumors … “Expired” COVID-19 tests may still be OK, feds say...
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...