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In a July 9 memo, the director of the FDA's Center for Biologics Evaluation and Research contended there was not enough ...
According to Makary, reducing user fees—which make up just under half of the FDA's budget—could make it easier for smaller ...
This is what it looks like when disinformation doctors pretend to value data and science to further their true objective, ...
Unlike Drs. Adam Cifu and John Mandrola, I do not constantly boast of my "nuance" or claim to be a master of "clinical ...
The U.S. Food and Drug Administration has declined to approve Capricor Therapeutics' cell therapy for a heart condition, the ...
In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy associated with Duchenne muscular dystrophy. The decision comes after CBER ...
The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., who has pushed for changes around mRNA ...
The nascent leadership team assembled by Kennedy consists of highly talented and respected experts in their fields. Let’s ...
After a season of regulatory upheaval, obesity and rare genetic diseases will likely remain major themes for biopharma in ...
Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.
The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.
Senior officials at the Food and Drug Administration appointed by the Trump administration, under Health and Human Services ...