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The FDA’S Antimicrobial Drugs Advisory Committee (ADAC) voted 16 to 1 on Thursday in favor of Pfizer’s antiviral Paxlovid (nirmatrelvir and ritonavir) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Read More
The FDA has announced that when the COVID-19 public health emergency declaration expires on May 11, many of the 72 guidances issued to address the pandemic and that are still in effect will be revised and remain in effect, while others will be allowed to expire.
Lagevrio is under Emergency Use Authorization for the treatment of mild-to-moderate COVID-19 adult patients who are at high risk of progression to severe COVID-19.
The agency said the conditions that created the need for the policy described in the document have evolved and the policy is no longer needed. Read More
A single injection of Eiger Biopharmaceuticals’ peginterferon Lambda, an immune defense-stimulating protein, cut the rate of COVID-19 hospitalization by 51 percent compared to placebo, researchers reported in the New England Journal of Medicine. Read More
As the Biden administration prepares to end the COVID-19 public health emergency on May 11, the FDA must decide what to do with dozens of temporary guidances issued during the public health emergency. Read More
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