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

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

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

Applied Therapeutics stock rises as the FDA no longer requires an Advisory Committee meeting, keeping the Priority Review on ...

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, ...

In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have increased from $2.09 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of ...

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 ...

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