On Feb. 10, pharmaceutical company Moderna announced that the FDA Center for Biologics Evaluation and Research (CBER) had refused to review its application to market an investigational mRNA-based flu ...

The FDA’s refuse-to-file letter cited no safety or efficacy concerns for Moderna’s influenza vaccine, mRNA-1010. The company said the agency’s justification for refusing a review is inconsistent with ...

The U.S. Food and Drug Administration (FDA) recently informed Moderna that it would not review the company’s application for ...

The move signals an escalation in the agency’s efforts to interfere with established procedures for testing and approving vaccines.

Moderna’s mRNA-1010 was expected to contribute $1 billion to the company’s coffers by 2028. That plan is now out the window ...

Ocular Therapeutix's current wet AMD treatment is dominated by anti-VEGF drugs, with EYLEA holding a 63% global market share ...

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The U.S. Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday.

Senior FDA official Vinay Prasad reportedly overrode his staff in deciding to reject Moderna's application for a new seasonal flu shot.

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