Articles by U.S. Food and Drug Administration

First home antibody test can inform patients of current or past infection and lead to confirmatory testing with healthcare provider

The US is experiencing interruptions in the supply of BD BACTEC blood culture media bottles because of recent supplier issues

The RNA-based test enables single-visit testing for HCV in about an hour, streamlining access to treatment

The new guiding principles promote transparency to build trust and improve the user experience of machine learning-enabled medical devices

The FDA announced a final rule amending the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act

The FDA granted the approval of Zevtera® to Basilea Pharmaceutica International Ltd.

The FDA granted the approval of Duvyzat™ to Italfarmaco S.p.A

The FDA granted approval of Lenmeldy™ to Orchard Therapeutics

The FDA granted the approval of Rezdiffra to Madrigal Pharmaceuticals

Users should not make medical decisions based on the device’s output without talking to their healthcare provider

The FDA granted the approval of Amtagvi to Iovance Biotherapeutics Inc.

The FDA granted the approval of Casgevy to Vertex Pharmaceuticals Inc., and Lyfgenia to Bluebird Bio Inc.

The FDA granted the approval of Ogsiveo to SpringWorks Therapeutics Inc.

Ixchiq is a single-dose, attenuated vaccine, safe to be administered to individuals above 18 years

The over-the-counter at-home COVID-19 test detects positive SARS-CoV-2 infection with 89.8 percent sensitivity