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 ...

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 ...

Shares of Applied Therapeutics APLT surged 68.8% on Wednesday after it announced a regulatory update regarding the ongoing ...

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 ...

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 ...

On August 8, 2024, the US Food and Drug Administration (FDA) partially revised the availability of certain glucagon-like peptide 1 (GLP-1) ...

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 ...