Biohaven announced topline results from its pivotal Study BHV4157-206-RWE, showing that troriluzole significantly slowed ...

Cullinan Therapeutics has filed an investigational new drug application with the U.S. Food and Drug Administration (FDA) for CLN-978 for the treatment of systemic lupus erythematosus (SLE).

FDA Accepts LEO Pharma’s Filing of Delgocitinib Cream New Drug Application for the Treatment of Chronic Hand Eczema ...

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 ...

Biohaven's drug for a genetic disease that affects the nervous system met the main study goal, sending its shares up more ...

Researchers from Stanford University and Rensselaer Polytechnic Institute have developed an advanced AI model that improves ...

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

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

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

In a significant move to streamline the regulatory submission procedure, the Directorate General of Health Services, Central ...