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

Financially, Rhythm has $319.1 million in cash, but may need to raise more funds within the next 12 months. See why I rate ...

Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), today announced positive topline results from pivotal Study BHV4157-206 ...

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 ...

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

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 ...

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 ...

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

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

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