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

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

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

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

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 ...

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

In a rare and surprising move, the FDA has issued a “Refusal to File” letter for Moderna’s mRNA-1010 influenza vaccine.

Rejecting a recently developed Moderna flu vaccine, the HHS continues to distance itself from mRNA research and development.

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna ...

A world-first pediatric mRNA cancer vaccine trial is launching in Australia that could open new possibilities for children with aggressive brain tumors. The Paedneo-Vax trial, funded by Canada’s ...

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