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

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

Moderna shares sink 10% after FDA issues Refusal-to-File letter for its mRNA-1010 flu vaccine, citing trial design concerns ...

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 ...

By Rashika Singh and Mariam Sunny Feb 11 (Reuters) - Shares of Moderna slumped over 10% on Wednesday after the U.S. Food and ...

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

The US FDA has refused to review Moderna’s mRNA flu vaccine application, citing concerns over its clinical trial comparator.

Moderna said the move is inconsistent with previous feedback from the FDA on the experimental influenza shot, called ...

CEO Stephane Bancel said the letter refusing review did not cite ‘any safety or efficacy concerns’.

Moderna received a surprise refusal from the FDA to review its updated flu vaccine, highlighting the ongoing struggle between vaccine makers and a vaccine-skeptical HHS.

The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.