Ascletis Pharma has received investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) to begin ...

FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject clinical ...

GH Research (NasdaqGM:GHRS) is back in focus after the FDA lifted the clinical hold on its IND for GH001, clearing the way for U.S. enrollment in treatment resistant depression trials. See our latest ...

Tradipitant is a selective human substance P/neurokinin-1 receptor antagonist approved for the prevention of vomiting induced by motion in adults.

After a lengthy downturn, the biotech industry finally gathered momentum in 2025. Key readouts in obesity, infectious disease ...

A UC San Diego lab recently announced a pair of scientific breakthroughs for Pitt-Hopkins and Rett syndromes that are slated ...

"Neumora’s Alzheimer’s disease agitation drug shows early success in Phase Ib trial" was originally created and published by ...

In a major shift for how mental health conditions might be treated, the US Food and Drug Administration (FDA) has approved ...

When Covid-19 vaccines roll out for the fall and winter respiratory illness season, they will continue to be based on the same lineage that is the basis for vaccines from this past season, but tweaked ...

The good news at the end of the year was that the FDA approved a pill form of the company's GLP-1 weight loss medication. The ...

The Trump administration’s latest effort to lower drug costs is expanding to biosimilars, medications that are highly similar to biologic drugs made with or isolated from living organisms such as ...

Under the new leadership of Marty Makary, the FDA should focus more attention on the critical role of real-world clinical data — such as from health insurance databases — in the ongoing assessment of ...