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.

XPOVIO® is the first and only approved XPO1 inhibitor in Thailand. XPOVIO® has been approved for multiple indications in nine markets across the APAC region. Antengene has submitted a new drug applica ...

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

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

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

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

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

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 ...

Generative AI can design never-before-seen proteins quickly and at scale, streamlining the drug design process like never ...

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