FDA Approves First Over-the-counter Combined COVID-19 and Flu Test

In late February, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization to an at-home diagnostic test that identifies SARS-CoV-2, the virus that causes COVID-19, as well as influenza strains A and B. The test detected 100% of negative and 88.3% of positive COVID-19 samples, 99.3% of negative and 90% of positive influenza A samples, and 99.9% of negative influenza B samples.

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Marzo 2023

Lecanemab Gains FDA Approval for Early Alzheimer Disease

A treatment that may moderately slow mild cognitive decline and reduce amyloid-β plaques in patients with early Alzheimer disease gained accelerated approval from the US Food and Drug Administration (FDA). Lecanemab-irmb, marketed as Leqembi by Eisai and Biogen, is indicated for patients with mild cognitive impairment or mild dementia due to Alzheimer disease.

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Febbraio 2023