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

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

Here is a recap of every FDA approval announced by the regulatory agency in the month of April, spanning various cancer types ...

On February 21, 2025, the FDA updated its drug shortage list and labeled the ... Among other differences from FDA-approved drug products, compounded drug products have not undergone FDA premarket ...

Stealth BioTherapeutics had expected the FDA to respond on Tuesday to its marketing application for elamipretide to treat ...

Over the coming months, the FDA will revoke authorization for two synthetic food colorings — Citrus Red No. 2 and Orange B — ...

The FDA has not approved ivermectin for use in treating or preventing COVID-19 infection in humans.” The Fox Business news clip is from an August 11, 2023, segment between Bartiromo and GOP Sen.

Many compounding pharmacies are no longer allowed to make cheaper versions of semaglutide and other GLP-1 drugs. A doctor explains options for patients.

U.S. health agencies announced that the food industry will begin "phasing out" eight artificial food dyes in the coming years ...

The delay for Stealth Biotherapeutics comes amid a heightened focus on the impact FDA job cuts might have on drug reviews.