Following an investigational new drug application clearance from the FDA, a phase 1 trial plans to evaluate CD-001.

After pushing back the decision date for Applied Therapeutics’ metabolic disorder drug govorestat, the FDA has now decided ...

A D.C. drugmaker has been dealt a major setback in its long-running bid to bring its treatment for a chronic gastrointestinal ...

Shares of Applied Therapeutics APLT surged 68.8% on Wednesday after it announced a regulatory update regarding the ongoing ...

The FDA has approved Zevra Therapeutics' Miplyffa (arimoclomol) as the first treatment for neurological symptoms of ...

The Food and Drug Administration (FDA) has cleared an investigational new drug application for the novel treatment, APTN-101, ...

Vanda pharmeucitals received a rejection for its drug tradipitant, causing the company management to criticize the FDA.

Discover how advances from various biotechs are bridging treatment gaps in menopause care, offering hope for managing ...

Applied Therapeutics shares jumped in premarket trading after the company said that its new drug application will proceed with a priority review with regulators without other delays. Shares traded ...

The U.S. Food and Drug Administration has declined to approve Vanda Pharmaceuticals' drug to treat stomach paralysis symptoms ...

The market for weight-loss treatments is expected to see 16 new drugs vying for a slice of the lucrative business currently ...

On World Alzheimer’s Day, we examine how a timely diagnosis can prepare someone with early dementia, and the pros and cons of ...