- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- On May 17, the FDA provided summary information about the status of CytoDyn, Inc.’s development program for the monoclonal antibody investigational drug, leronlimab, for the treatment of COVID-19. The data currently available from recent CytoDyn clinical trials do not support the clinical benefit of leronlimab for the treatment of COVID-19.
- The Janssen (Johnson & Johnson) COVID-19 Vaccine Fact Sheet for Recipients and Caregivers has been updated and is available in multiple languages.
- Testing updates:
- As of today, 374 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 272 molecular tests and sample collection devices, 78 antibody and other immune response tests, and 24 antigen tests. There are 50 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, four antigen over-the-counter (OTC) at-home tests, and two molecular OTC at-home tests.
- The FDA has authorized nine antigen tests and four molecular tests for serial screening programs.
The FDA has also authorized 505 revisions to EUA authorizations.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.