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,...
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.
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.
FDA reduces recommended salt levels in Americans’ food
Oct 13, 2021
The new, voluntary guideline aims to reduce average sodium intake from 3,400 to 3,000 mg per day in the next 2.5 years
FDA approves digital antipsychotic pill to track patient data
By
Nov 14, 2017
A new type of antipsychotic pill approved by the Food and Drug Administration will be able to share information about when it was taken with patients and providers — but it comes with a warning for older...
Promising antidepressant fails in late-stage trial
By
Alicia Lasek
Dec 05, 2019
Fast-tracked antidepressant Sage-217 failed to outperform a placebo in a stage 3 trial, according to its developer.
Moderna’s vaccine highly effective against COVID-19: FDA review
By
John O'Connor
Dec 16, 2020
Moderna’s COVID-19 vaccine is 94% effective in preventing symptomatic illness, according to information released Tuesday. The initial review’s findings appear to set the table for federal authorization...