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

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 ...

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

FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and ...

Tamarack Biotics’ TruActive process targets pathogens with UV light while keeping the milk’s enzymes and proteins intact.

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

A Food and Drug Administration expert panel has reignited a debate over whether hormone therapy should be used to treat ...

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...