The FDA Center for Drug Evaluation and Research has accepted a letter of intent for the first biomarker for idiopathic pulmonary fibrosis into its Biomarker Qualification Program, according to a press ...

6:14 p.m. July 24, 2025: An earlier version of this article said the name of the chief of maternal and fetal medicine at MetroWest Medical Center in Framingham, Mass., is Dr. David Urato. He is Dr.

The Xpert GI Panel identifies pathogens directly from stool specimens collected in Cary-Blair transport media.

An Food and Drug Administration expert panel on Thursday endorsed removing the "black box" warning on hormone treatments for menopause that critics say have discouraged women for decades from using ...

In a rare move, an advisory FDA panel voted 14-1 Oct. 19 in support of retracting Makena, the only treatment approved to help prevent preterm birth, from the market, which the agency fast-tracked and ...

A Food and Drug Administration panel on Wednesday advocated for regulatory changes that would make testosterone medications more widely accessible, including removing their classification as ...

After two attempted votes followed by computer glitches and giggles, the FDA panel to assess restrictions on the diabetes drug Avandia narrowly voted Thursday to modify the restrictions. Avandia, a ...