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 ...
Biohaven Stock Spikes After Drug Candidate To Treat Rare Neurodegenerative Disease Shows Promise
Biohaven announced topline results from its pivotal Study BHV4157-206-RWE, showing that troriluzole significantly slowed ...
Biohaven surges as genetic disease drug meets main study goal
Biohaven's drug for a genetic disease that affects the nervous system met the main study goal, sending its shares up more ...
FDA Accepts LEO Pharma’s Filing of Delgocitinib Cream New Drug Application for the Treatment of Chronic Hand Eczema
FDA Accepts LEO Pharma’s Filing of Delgocitinib Cream New Drug Application for the Treatment of Chronic Hand Eczema ...
Lupus Foundation of America1h
Cullinan Therapeutics Files Investigational New Drug Application with FDA for CLN-978 for Treatment of Systemic Lupus Erythematosus
Cullinan Therapeutics has filed an investigational new drug application with the U.S. Food and Drug Administration (FDA) for CLN-978 for the treatment of systemic lupus erythematosus (SLE).
Targeted Oncology3d
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.
Daily1d
CDSCO Implements Online System for Veterinary Drug Applications on SUGAM Portal
In a significant move to streamline the regulatory submission procedure, the Directorate General of Health Services, Central ...
FierceBiotech5d
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 ...
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 ...
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 ...
New AI model enhances clinical trial approval predictions by quantifying uncertainty
Researchers from Stanford University and Rensselaer Polytechnic Institute have developed an advanced AI model that improves ...
US FDA declines to approve Vanda's stomach condition drug
The U.S. Food and Drug Administration has declined to approve Vanda Pharmaceuticals' drug to treat stomach paralysis symptoms ...