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

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

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

The U.S. Food and Drug Administration has declined to approve Capricor Therapeutics' cell therapy for a heart condition, the ...

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

The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally ...

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.

Congress is expected to vote next week on President Donald Trump’s request to claw back $9.4 billion in congressionally ...

Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.

COVID-19 vaccine mandate critic Vinay Prasad has been named as director of the FDA's Center for Biologics Evaluation and Research (CBER) ...

The nascent leadership team assembled by Kennedy consists of highly talented and respected experts in their fields. Let’s ...