In a July 9 memo, the director of the FDA's Center for Biologics Evaluation and Research contended there was not enough ...

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

According to Makary, reducing user fees—which make up just under half of the FDA's budget—could make it easier for smaller ...

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

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

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

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

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

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 FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...