The Food and Drug Administration is requiring manufacturers of certain sleeping pills, including the widely prescribed Ambien, to reduce current recommended dosages.
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.
FDA OKs third antibody COVID therapy; variants spur new pause on another
By
Alicia Lasek
Jun 01, 2021
A new COVID-19 treatment made by GlaxoSmithKline now is the third monoclonal antibody therapy federally authorized to help prevent severe disease outcomes in high-risk patients. But gene variants are interfering...
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. COVID-19 strategy must veer to protecting the vulnerable, experts say
By
Alicia Lasek
Mar 22, 2022
When planning for a future with COVID-19, some clinicians believe that the public health focus should turn from stopping transmission to protecting those most likely to become severely ill, according to...
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...