Learn about Rhythm Pharmaceuticals' FDA-approved drug IMCIVREE for obesity, including its potential expansion to children and ...

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

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 ...

Update on FDA's Applied Therapeutics, Inc. decision to remove advisory panel for govorestat review in treating galactosemia.

Targeting two receptors instead of the one targeted by fezolinetant, the new elinzanetant did not show the liver safety ...

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 ...

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

IPF is a rare progressive fibrosing interstitial lung disease with symptoms that include breathing difficulty, dry and persistent cough, chest discomfort and fatigue. The randomized, double-blind, ...

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