Trump’s health secretary has halted federal flu vaccine promotions, citing personal beliefs about vaccine risks.
In a major blow to vaccine development, the FDA said it will not review Moderna’s application for the first mRNA-based flu shot.
The agency previously told Moderna its application did not contain an “adequate and well-controlled” trial.
Just last week, the agency rejected Moderna’s initial application, citing flaws in the company’s research design.
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.
By Mariam Sunny and Michael Erman Feb 13 (Reuters) - Moderna said it is looking for growth overseas after the U.S. FDA ...
Moderna announced that the FDA agreed to review its application for a mRNA-based flu vaccine after it agreed to further study in older adults.
The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said Tuesday, in another setback for the technology ...
On Feb. 10, pharmaceutical company Moderna announced that the FDA Center for Biologics Evaluation and Research (CBER) had refused to review its application to market an investigational mRNA-based flu ...
I wouldn’t go so far as to categorize the pandemic as the “good old days,” but during the 2020-2021 flu season, only 1,316 positive flu cases were reported in the U.S. Why? Because most of us were ...