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

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

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

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Ele­vidys, after three patients died from ...

The move follows the death of two teenagers who were administered the treatment, as well as the death of a 51-year-old ...

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

Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger ...

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

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

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

With returning characters, a fresh villain and a high-stakes digital war, the new season of Special Ops is a hit, writes I’ve been a fan of Special Ops ever since it first released during the COVID-19 ...

The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...