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

The Food and Drug Administration rejected Moderna's new flu shot. This raises questions about what it means for the future of vaccine development.

The head of the agency’s vaccine division, Vinay Prasad, has overruled pushback from career staffers.

The 2024-2025 flu season resulted in 266 pediatric deaths, with 90% of the children who died being eligible for a flu vaccine ...

Initial data from 180 participants are anticipated within the year.

The vaccine maker’s shots involve the successful Covid vaccines’ RNA technology. Health Secretary Robert F. Kennedy Jr. has ...

The Food and Drug Administration on Wednesday defended its rejection of Moderna’s mRNA-based flu vaccine application, saying the company’s clinical trial design put patients at risk ...

Moderna noted the FDA did not identify any specific safety concerns with the vaccine and that the rejection was inconsistent with previous feedback.

By Mariam Sunny and Michael Erman Feb 11 (Reuters) - A U.S. Food and Drug Administration official on Wednesday defended the ...

The flu vaccine is its first using mRNA technology for influenza.

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

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