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

The culture of academic medicine needs to change, FDA Commissioner Marty Makary, MD, MPH, said at an event sponsored by The ...

George Tidmarsh appointed to lead FDA drug review division amid staffing cuts and scrutiny over accelerated approvals and ...

Johnson & Johnson eyes FDA nod to icotrokinra after phase III studies show strong skin clearance and safety in plaque ...

The drop comes the day after the drugmaker said it would add a so-called black-box warning to its gene therapy Elevidys after ...

An analysis from the Congressional Budget Office warns that cuts to the National Institutes of Health and FDA drug reviews could significantly reduce the number of new medications reaching the U.S.

Scientists at UCSF and Gladstone Institutes have identified cancer drugs that promise to reverse the changes that occur in ...

Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to ...

Alzheimer’s disease remains one of medicine’s toughest challenges, affecting millions and costing trillions of dollars ...

Researchers say that a pair of already FDA-approved medications could reverse brain changes in the most common form of ...

Scientists at UC San Francisco and Gladstone Institutes have identified cancer drugs that promise to reverse the changes that ...

The U.S. Food and Drug Administration made the controversial decision to authorize the sale of Juul e-cigarettes, including ...