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 ...

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

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, ...

Yale Child Study Center at the Yale School of Medicine in the USA, Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in ...

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 ...