Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

AstraZeneca Iressa NDA Review Complicated By Pneumonia Reports

Executive Summary

The final FDA review of AstraZeneca's Iressa NDA is being complicated by reports of interstitial pneumonia possibly associated with use of the non-small cell lung cancer agent

You may also be interested in...



Iressa Clears FDA: Phase IV Symptom Trial Will Be First Shot At Full Approval

AstraZeneca's first chance to secure traditional approval for Iressa will be a randomized trial assessing symptom improvement in non-small cell lung cancer due to be submitted to the agency by June 2005

Iressa Clears FDA: Phase IV Symptom Trial Will Be First Shot At Full Approval

AstraZeneca's first chance to secure traditional approval for Iressa will be a randomized trial assessing symptom improvement in non-small cell lung cancer due to be submitted to the agency by June 2005

Iressa Postmarketing Trial Modeled On Tarceva Phase III Under Consideration

FDA is understood to be considering the design of OSI/Genentech/Roche's Tarceva Phase III trial in refractory non-small cell lung cancer as a model for a postmarketing trial for AstraZeneca's Iressa

Related Content

UsernamePublicRestriction

Register

PS040711

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel