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...
FDA warns of heart-related events for arthritis drug Xeljanz and others in its class
By
Alicia Lasek
Sep 02, 2021
The agency is requiring a warning label on the arthritis and ulcerative colitis drugs Xeljanz and Xeljanz XR (tofacitinib) and two other drugs in this class, citing an increased risk of adverse health...
Clinical Daily Briefs for Thursday, March 26
By
Alicia Lasek
Mar 25, 2020
Argentum, AHCA / NCAL launch campaigns to share positive messages during pandemic … Clinic study shows where surface-cleaning efforts can fall short … CVS moves to prevent hoarding of malaria drug...
FDA requires abuse warning on Xanax, Valium labels
By
Alicia Lasek
Sep 25, 2020
Benzodiazepine drug labels must now display the FDA’s most serious “boxed warning” following growing reports of sedative abuse, the agency announced Thursday.
Clinical briefs for Thursday, Oct. 14
By
Alicia Lasek
Oct 14, 2021
New CDC effort will track impact of COVID-19 and other public health threats on long-term care facilities … FDA pushes to cut sodium by 12% in American foods in bid to confront chronic disease epidemic...
Clinical briefs for Thursday, June 10
By
Alicia Lasek
Jun 10, 2021
Operator changes plans, will wait for full FDA approval to enforce COVID vaccination deadline among staff … Colorado drops mask mandate for assisted living communities … FDA panel member resigns over...
U.S. lawmakers ramp up scrutiny of FDA following agency’s approval of controversial Alzheimer’s drug
By
Alicia Lasek
Sep 07, 2021
The FDA is being asked to help explain how Aduhelm (aducanumab) met accelerated approval criteria when so many experts — including internal advisers — have flagged insufficient safety and efficacy...
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.