Moderna said the U.S. Food and Drug Administration has agreed to review its influenza vaccine, reversing an earlier decision to reject the application.
Last week, Moderna said that the initial refusal from the FDA was inconsistent with previous feedback from the agency.
The NJ DEP has received over 1,100 calls for dead wild birds. Harsh winter conditions and possible bird flu are suspected ...
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 ...
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The agency previously told Moderna its application did not contain an “adequate and well-controlled” trial.
One week after saying it was refusing to review Moderna’s application for approval of a new flu vaccine, the US Food and Drug ...
The US Food and Drug Administration will now review Moderna’s new, messenger RNA–based flu vaccine after all, reversing course on a decision that rocked the biopharmaceutical industry last week.
With the reversal from the FDA, Moderna said it is aiming to make the vaccine available for the 2026-27 flu season.
The FDA is slated to make a decision on the flu shot on Aug. 5, which will allow Moderna to make the vaccine available for the upcoming influenza season.
Moderna held further discussions with regulators and announced that the agency would accept the company’s application for approval of its flu vaccine that uses mRNA technology.
Officials in New Jersey are reporting that over one thousand geese have died over the last few days raising new concerns over ...