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

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

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

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

FDA refuses Moderna's mRNA flu vaccine application, citing inadequate study design, as the company disputes decision, saying it contradicts prior FDA guidance.

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

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

A new case report was published in Volume 17 of Oncotarget on February 6, 2026, titled “Exploring the potential link between ...

The F.D.A.’s refusal to examine the company’s mRNA shot drew widespread criticism from doctors and was divisive within the agency.

HealthDay News — In a major blow to vaccine development, the US Food and Drug Administration (FDA) said it will not review Moderna’s application for the first mRNA-based flu shot. Dr Vinay Prasad, the ...