The Food and Drug Administration rejected Moderna’s application for its mRNA-based flu vaccine, the drugmaker said Tuesday ...

Moderna took the unusual step of announcing the FDA’s refusal and releasing the agency’s letter. The letter states that ...

Presented by the Coalition to Strengthen America’s Healthcare{beacon} Health Care Health Care The Big Story FDA refuses ...

The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with mRNA ...

Moderna said on Tuesday that the Food and Drug Administration (FDA) has refused to review its application for an mRNA flu ...

Moderna stock is rated Sell amid FDA setbacks for mRNA-1010, commoditized COVID/RSV sales, and cash burn. Read the analysis ...

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said Tuesday, in another setback for the technology ...

The decision, which shocked company officials, comes as the FDA says it will take a stricter approach to federal vaccine approvals.

Moderna (MRNA) stock fell 0.3% Friday despite beating Q4 revenue estimates at $678M and posting narrower loss of $2.11/share after FDA rejected flu vaccine review.

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

In a news release late Tuesday, Moderna said it was blindsided by the FDA’s refusal, which the FDA cited as being due to the design of the company’s Phase 3 trial for its mRNA flu vaccine, dubbed mRNA ...