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 responds to provider pressure, backs off stricter control of fecal transplants for C. diff
By
McKnight's Staff
Jun 19, 2013
Individuals with treatment-resistant Clostridium difficile can undergo fecal transplants after giving informed consent, the Food and Drug Administration recently announced. This is a victory for providers,...
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,...
Expect false positives: FDA letter to providers explains COVID antigen test results
By
Alicia Lasek
Nov 05, 2020
The agency clarifies that rapid antigen tests, “like all diagnostic tests,” are subject to false positive results, especially in low prevalence settings. It offers recommendations for administering...
Biogen seeks FDA approval for Alzheimer’s drug; aims to be first to slow disease
By
Alicia Lasek
Jul 09, 2020
Treatment with aducanumab reduced declines in memory, language, and activities of daily living performance, the drugmaker says.
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.
Pharmacists object to further restrictions for hydrocodone combination products
By
Elizabeth Newman
Aug 25, 2014
Hydrocodone combination products such as Vicodin will now be in the same, more-restrictive category as OxyContin and fentanyl under the Controlled Substances Act, the Drug Enforcement Administration announced...
Hydrocodone restrictions not coming soon, FDA says
By
McKnight's Staff
Mar 15, 2013
Restricting access to hydrocodone painkillers will require a lengthy process unless Congress takes action, the Food and Drug Administration recently told lawmakers.
Covidien targets wound care product shortage
Jan 30, 2013
Covidien will make more of its cotton-based wound care products at its Augusta, GA, locating. The move is part of an effort to prevent possible supply shortages.