It’s rare that FDA refuses to file an application, particularly for a new vaccine, which requires companies and FDA staff to ...

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

HHS Spokesman Andrew Nixon told The National News Desk via email that the FDA rejected Moderna’s application for filing ...

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

The Food and Drug Administration on Wednesday defended its rejection of Moderna’s mRNA-based flu vaccine application, saying ...

COVID-19 vaccination during pregnancy shows no link to autism or developmental delays in young children, according to new research.

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

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

The mRNA COVID-19 vaccine is not associated with autism or other neurodevelopmental problems in children whose mothers ...

Moderna (MRNA) stock fell 9% premarket after FDA rejected its flu vaccine application due to trial design issues, despite ...