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

Spectrum's Apaziquone Pooled Analysis Can't Make Up For Negative Studies

Executive Summary

Faced with two unsuccessful pivotal trials, FDA advisory committee concludes substantial evidence of a treatment effect in non-muscle invasive bladder cancer has not been demonstrated.

You may also be interested in...



Keeping Track: FDA Approves First Rx DHEA, Receives Applications For Midostaurin, Gesulkumab, Biosimilar Avastin

The latest drug development news and highlights from our FDA Performance Tracker.

A Cautious Guide To The Interpretation Of Clinical Trials From NEJM

Determining the success or failure of a randomized trial requires looking beyond the p-value for the primary endpoint, review articles in The New England Journal of Medicine urge.

FDA Oncology Advisory Committee Is Still Pazdur’s Center of Excellence

Richard Pazdur is moving to a new role in FDA as part of a reorganization driven by the Cancer 'Moonshot.' The most recent Oncologic Drugs Advisory Committee meeting, however, demonstrates that he is still very much in command of cancer drug reviews.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID005817

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