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...
FDA advisers to vote on first drug to treat Alzheimer’s
By
Alicia Lasek
Oct 28, 2020
Advisers will consider whether to recommend that the amyloid beta-removing drug aducanumab be approved. The FDA has not reviewed an application for a new Alzheimer’s treatment for at least 15 years.
FDA approves fast-results antigen test for COVID-19
By
Alicia Lasek
May 11, 2020
The first federally approved test of its kind, the point-of-care diagnostic is administered using a nasal swab.
Boosters on the way: LTC residents, healthcare workers may top fed’s list after CDC approves 3rd shot
By
Alicia Lasek
Aug 16, 2021
The Biden administration has secured 100 million COVID-19 vaccine doses as part of a strategy to provide additional shots to already vaccinated priority groups this fall, investigators have been told....
CDC briefing: Top officials talk up vaccine plans, focus on long-term care
By
Alicia Lasek
Oct 22, 2020
Federal health officials touted transparency and nationwide distribution plans while keeping their eye on Phase 1 vaccine recipients, including LTC residents and workers.