The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.

By Sneha S K Feb 10 (Reuters) - The U.S. Food and Drug Administration will not review Moderna's approval application for its ...

The Food and Drug Administration has refused to review an application from the biotech company Moderna to approve its mRNA-based flu vaccine. The agency’s decision, which Moderna announced in a press ...

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu ...

Moderna received a refusal-to-file letter from the FDA objecting to how it conducted a 40,000-person trial comparing its new ...

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For those considering graduate school, the application process can seem overwhelming. What should be included in a statement of purpose? What programs should be explored? Who should write letters of ...

The Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with mRNA technology, the company said.

News is latest sign of the agency's heightened scrutiny of vaccines ...

As Granite State Democrats seek to officially reclaim the first-in-the-nation spot on the Democratic National Committee’s ...