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

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

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

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

Obeticholic acid had been awarded accelerated approval by the FDA in May 2016 as a second-line treatment for PBC patients not ...

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 ...

Timely toxicology material delivery is crucial for IND and CTA approvals, helping to advance drug candidates efficiently to ...

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 ...

Granting patents to US firm Gilead Sciences for lenacapavir could hinder global efforts to end AIDS & restrict access to ...

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

New machine learning techniques plumb vast "data lakes" to help researchers design faster, cheaper, more effective clinical ...

Lenacapavir, a very expensive drug, is not available in India and many other countries. If the Indian Patent Office clears ...