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 ...

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 ...

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 ...

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

Launched in 2020 to more quickly bring to market an effective medicine for amyotrophic lateral sclerosis, the HEALEY Platform ...

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

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

Patient and public health groups worry about a potential patent grant to Gilead Sciences for the HIV drug lenacapavir in ...

Developing advanced drug screening tools is crucial for the advancement of personalized medicine and the creation of more effective treatments. One organ receiving particular attention in this area is ...