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.
Managed Healthcare Executive4d
IPF Drug Meets Primary End Point
Boehringer Ingelheim said that it will submit a new drug application for nerandomilast based on the positive results.
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 ...
Applied Therapeutics Stock Soars As FDA Scraps Panel Meeting For Its Inherited Metabolic Disorder Drug
Applied Therapeutics stock rises as the FDA no longer requires an Advisory Committee meeting, keeping the Priority Review on ...
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 ...