Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...

The U.S. Food and Drug Administration is asking some of its recently fired staff responsible for critically important funding ...

The drug cytisinicline could help expand options for quitting smoking, and if approved by the FDA, would be the first new ...

Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...

Confusion over the FDA delay in granting full approval to Novavax’s Covid-19 vaccine deepened over the weekend, with possible ...

An approval decision for Stealth BioTherapeutics’ investigational treatment for an ultra-rare genetic disease has been ...

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve COVID-19 vaccines for next winter, citing a lack of data on booster shots.

A shocking report on mifepristone has finally shown a light on how the FDA is harming, and even killing, thousands of women.

In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have ...

The notion that we can simultaneously demand expedited approvals while gutting the agency is misguided.

“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to ...