Home » ENCYSIVE SUBMITS THELIN RESPONSE TO FDA

ENCYSIVE SUBMITS THELIN RESPONSE TO FDA

May 25, 2006

Shares of Encysive Pharmaceuticals Inc. soared in early trading on Thursday as the pharmaceutical company said it submitted a complete response to the U.S. Food and Drug Administration regarding the company's new drug application for Thelin.
The Houston Chronicle

KEYWORDS FDAnews Drug Daily Bulletin

08Sep
Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections
15Sep
Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis
20Sep
Building a World-Class Pharmaceutical Advertising and Promotion Review Program
21Sep
The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval
22Sep
FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers
11Oct
1st Annual Quality Management vSummit

ENCYSIVE SUBMITS THELIN RESPONSE TO FDA

Upcoming Events

Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

Building a World-Class Pharmaceutical Advertising and Promotion Review Program

The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

1st Annual Quality Management vSummit

Featured Products

FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

AngioDynamics Gets Expanded Clearance for Auryon Atherectomy System

Aura Biosciences Receives Fast Track Designation for Bladder Cancer Candidate

FDA Issues Update on Becton Dickinson’s Recall

FDA Grants Accelerated Approval to Enhertu for HER2-Mutant NSCLC

The Revised ICH E8: A Guide to New Clinical Trial Requirements