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

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

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

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

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

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and ...

The FDA approved a label update with a new titration schedule for donanemab (Kisunla), an anti-amyloid drug approved to treat ...

In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug ...

A Cambridge-based company developing gene therapies for rare diseases is laying off more than a third of its workforce.

Months after the FDA approved three natural food additives, it's added another to the list. Experts share what parent should ...

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