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

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.

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

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

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

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

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

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 ...

Drugmaker Sarepta Therapeutics said late Friday it won't comply with a request from the Food and Drug Administration to halt ...

Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s ...