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

Vinay Prasad overruled other reviewers for a third time in recent months in clearing only narrow use of Moderna's vaccine in ...

The drastic cost-cutting move follows the deaths of two teenagers that forced the company to restrict usage of its gene ...

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 ...

Sarepta Therapeutics Inc. is cutting more than one-third of its workforce and will add a black box warning label to its gene therapy for a fatal muscle disorder after two patient deaths raised doubts ...

Participants in trials of BrainStorm Cell Therapeutics' NurOwn filed a Citizens’ Petition with the FDA earlier this month ...

To be able to identify such sectors that can become '"pockets of value" for wealth creation, Vinay Jaising, chief investment ...

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

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 ...