OH and the leaf of the kratom plant are not analogous, but as the former is a derivative of the latter, it has opioid-like qualities that make its susceptibility to abuse concerning.

Tidmarsh will temporarily guide CBER’s regulatory activities while the FDA searches for a permanent department lead.

In a memo, CEO Stéphane Bancel said the job cuts are needed to align the struggling vaccine maker’s cost structure with the ...

Donald Trump reportedly ignored calls from Health Secretary Robert F. Kennedy Jr. not to fire the top vaccine official at the Food and Drug Administration after a pressure campaign from far-right ...

But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...

The president overruled his HHS secretary and FDA chief, four people with knowledge of the decision tell POLITICO.

The last couple of weeks has been particularly distressing for Duchenne muscular dystrophy patients and their families. The ...

In a 51–47 vote along party lines, the Senate confirmed Monarez as the director of the Centers for Disease Control and ...

In the latest episode of STATus Report, Alex Hogan breaks down the confusing, heartbreaking saga of Sarepta and its gene ...

In this week’s edition of InnovationRx, we look at Halle Berry’s menopause startup, Ambience Healthcare’s $243 million ...

Vinay Prasad, who came under fire from patient advocacy groups and Laura Loomer, is gone after less than three months on the ...

Vinay Prasad exits FDA's biologics division following pressure over Sarepta's Elevidys approval and regulatory controversies.