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 ...

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

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 ...

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

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 ...

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

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

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 ...