FDA halts use of REGEN-COV, Eli Lilly monoclonal antibodies
By
Alicia Lasek
Jan 26, 2022
The Food and Drug Administration has revoked its emergency use authorizations for two monoclonal antibody cocktails that have served as COVID-19 treatment mainstays in long-term care facilities.
FDA set to approve two COVID-19 antiviral pills this week
By
Alicia Lasek
Dec 22, 2021
FDA is expected to grant emergency use authorization to two antiviral COVID-19 pills this week, possibly as early as today, according to Bloomberg News, citing sources familiar with the matter.
Feds gauging threat to vaccine, test and treatment efficacy in face of omicron variant
By
Alicia Lasek
Dec 01, 2021
The United States is prepared to address any potential threat to the effectiveness of COVID-19 vaccines, tests and treatments posed by the new variant, according to the White House and federal health officials.
FDA moves to discard hearing aid prescription rule in favor of OTC devices
By
Alicia Lasek
Oct 20, 2021
Adults with mild to moderate hearing loss would be able to obtain certain air-conduction hearing aids without a prescription under a new proposed rule. Whether this change would benefit long-term care...
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 advisers recommend Moderna COVID booster for seniors, others at high risk
By
Alicia Lasek
Oct 15, 2021
In a unanimous vote, advisers agreed that vulnerable Moderna vaccine recipients should be offered a third shot. A half dose will be effective and will help protect against side effects, the drugmaker says.
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...
Merck to seek emergency use for COVID-19 antiviral pill that cuts severe outcomes by 50 percent
By
Alicia Lasek
Oct 04, 2021
Molnupiravir has reduced COVID-19 deaths and hospitalizations by half in a new clinical trial. An orally delivered drug could offer unprecedented treatment convenience, the drug’s developers say.
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 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...