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...
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...
Vaccinated long-term care residents in the clear from COVID-19 — for now
By
Danielle Brown
Jul 12, 2021
Long-term care residents and staff fully vaccinated against COVID-19 don’t need booster shots anytime soon, according to federal health officials.
Ambien alternative? FDA approves insomnia drug that improves sleep in seniors
By
Alicia Lasek
Jan 01, 2020
New insomnia medication lemborexant compared favorably to an extended release form of Ambien in a late-stage clinical trial.
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...
First appropriate use guidance published for Alzheimer’s drug Aduhelm
By
Alicia Lasek
Jul 28, 2021
The new guidelines cover how to choose appropriate patients, safely scale up to a full dose, monitor side effects and assess effectiveness. The authors also address when to stop therapy and what patients...
Fecal transplants to treat C. diff now need FDA approval
By
McKnight's Staff
May 17, 2013
The Food and Drug Administration is moving to tighten regulations around fecal transplants, which research has shown to be an effective treatment for Clostridium difficile infection.