The letter was issued more than a month ahead of the FDA's scheduled priority review date of August ... set to face increased ...

In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...

Unlike Drs. Adam Cifu and John Mandrola, I do not constantly boast of my "nuance" or claim to be a master of "clinical ...

The company said it was “surprised” by the decision, which followed the ouster of multiple cell and gene therapy officials from the agency during deramiocel’s review.

The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.

The government’s top vaccine official working under Health Secretary Robert F. Kennedy Jr. recently restricted the approval ...

The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use ...

The leader of the U.S. FDA's division that oversees vaccines, Vinay Prasad, overruled the recommendations of his agency's ...

The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., who has pushed for changes around mRNA ...

This is what it looks like when disinformation doctors pretend to value data and science to further their true objective, ...

The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

FDA vaccine head Vinay Prasad restricted Moderna and Novavax COVID vaccines to high-risk groups, overriding staff advice amid ...