Last week, Moderna said that the initial refusal from the FDA was inconsistent with previous feedback from the agency.

Moderna said the U.S. Food and Drug Administration has agreed to review its influenza vaccine, reversing an earlier decision to reject the application.

The NJ DEP has received over 1,100 calls for dead wild birds. Harsh winter conditions and possible bird flu are suspected ...

From a potential new flu vaccine to a groundbreaking surgical first and critical health reminders, here's today's essential health news.

By Mariam Sunny and Michael Erman Feb 18 (Reuters) - Moderna said on Wednesday the U.S. Food and Drug Administration changed course and will review an amended application for its new flu vaccine, a ...

At issue with Moderna's mRNA flu shot is communication from CBER to Moderna suggesting that the company’s vaccine be compared ...

The agency previously told Moderna its application did not contain an “adequate and well-controlled” trial.

The U.S. Food and Drug Administration announced recently that it will not review Moderna’s mRNA flu vaccine, despite late-stage trials showing it was safe and effective. The rejection has many in and ...

The anti-science, anti-medicine mindset of the nutso Health and Human Services Secretary Robert F. Kennedy Jr. is killing ...

The anti-science, anti-medicine mindset of the nutso Health and Human Services Secretary Robert F. Kennedy Jr. is killing people by quashing life-saving vaccines. There is no other explanation why ...

One week after saying it was refusing to review Moderna’s application for approval of a new flu vaccine, the US Food and Drug Administration's (FDA’s) Center for Biologics Evaluation and Research ...

The FDA’s refuse-to-file letter cited no safety or efficacy concerns for Moderna’s influenza vaccine, mRNA-1010. The company ...