The FDA rejected Stealth BioTherapeutics’ latest bid to market its proposed treatment for an ultra-rare genetic condition, ...

In the wake of sweeping cuts at the FDA’s Office of Prescription Drug Promotion (OPDP), Sen. | In the wake of sweeping cuts ...

A union representing 150,000 federal workers faces allegations of financial improprieties. In an era of mass federal layoffs, ...

Keros will also stop work on a cardiovascular disease drug. Elsewhere, Stealth Biotherapeutics and Taysha Gene Therapies each ...

Researchers estimated 7.5% more U.S. children would get cavities, affecting 25.4 million additional teeth, if fluoridation ...

The White House said it will fix errors in a much-anticipated federal government report spearheaded by U.S. Health and Human ...

The Company believes Charlie's 640 PMTA products, as a stand-alone asset, have a monetary value that far exceeds Charlie's ...

Elon Musk's brief but controversial tenure as head of the Department of Government Efficiency (DOGE) concluded on May 28, ...

Almost nobody heard about the now-fatal reappearance of the E. coli virus that killed one person and sickened 90 last fall.

Although the FDA has rejected Stealth’s new drug application for Barth syndrome candidate elamipretide, the agency identified ...

As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and ...

Federal health officials say at least 45 people in 18 states have been sickened in an expanding salmonella outbreak tied to ...