FDA Declines Review of Moderna’s Experimental Flu Vaccine Application

The FDA (U.S. food and drug regulator) has refused to review Moderna’s application for its experimental influenza shot, signaling a regulatory setback for the biotech firm.

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Terms & Concepts
  • FDA (U.S. food and drug regulator): The Food and Drug Administration is responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, vaccines, and medical devices.
  • Experimental Flu Vaccine: A vaccine in development intended to provide protection against influenza, which has not yet completed required clinical trials.