FDA rejects Vanda Pharmaceuticals' application to bring key drug to market
A D.C. drugmaker has been dealt a major setback in its long-running bid to bring its treatment for a chronic gastrointestinal ...
Targeted Oncology1d
FDA Clears Investigational New Drug Application for CD-001 in Oncology
Following an investigational new drug application clearance from the FDA, a phase 1 trial plans to evaluate CD-001.
Cure Today13d
FDA OKed New Drug Application for Novel Glioblastoma Treatment
The Food and Drug Administration (FDA) has cleared an investigational new drug application for the novel treatment, APTN-101, ...
Another AZ county joins federal program to combat drug trafficking
Yavapai County will be part of the High Intensity Drug Trafficking Area program, which opens up federal resources to police drug trafficking.
FierceBiotech3d
FDA scraps adcomm for Applied's rare disease drug ahead of November decision
After pushing back the decision date for Applied Therapeutics’ metabolic disorder drug govorestat, the FDA has now decided ...
Zevra Therapeutics' Drug Becomes First FDA-Approved Treatment For Ultra-Rare Neurodegenerative Disease
The FDA has approved Zevra Therapeutics' Miplyffa (arimoclomol) as the first treatment for neurological symptoms of ...
U.S. FDA declines to approve Vanda's stomach paralysis drug
The U.S. Food and Drug Administration has declined to approve Vanda Pharmaceuticals' drug to treat stomach paralysis symptoms ...
Can you delay Alzheimer’s? How a new dementia screening test and drug may help
On World Alzheimer’s Day, we examine how a timely diagnosis can prepare someone with early dementia, and the pros and cons of ...
Applied Therapeutics Shares Rise as Drug Continues with Priority Review
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 ...
Business Wire7d
Positive Pooled Data from Nuvation Bio’s TRUST-I and TRUST-II Studies Highlight Taletrectinib’s Best-in-Class Potential for Patients with Advanced ROS1-positive NSCLC ...
Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today a ...
Edgewise: Stock Is Bouncing On Heart Disease Drug Data, Albeit From Just 7 Patients (Rating Upgrade)
Edgewise's lead drug, Sevasemten, remains unchanged in its potential, with ongoing pivotal studies for Becker Muscular ...
APLT Stock Soars 69% on Positive Update on Galactosemia Drug NDA
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 ...