After months of uncertainty, the Food and Drug Administration offered accelerated approval for an ultra-rare disease drug ...

The U.S. Food and Drug Administration said on Friday it had approved Stealth Biotherapeutics' once-daily injection for a rare, genetic disease that primarily affects males, making it the first ...

New tobacco products must submit a PMTA and receive authorization, or a marketing granted order (MGO), from the FDA in order to be legally sold in the United States. In January, the FDA issued MGOs to ...

Stealth’s injection, known as elamipretide, will be sold as Forzinity for the treatment of Barth syndrome, an X-linked ...

INDIANAPOLIS — The approach used to clear a homeless encampment in Fountain Square is being called a "proof of concept" by advocates for the homeless and city leaders. After extended delays, the ...