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


Accelerated Approval Program’s Future Is On The Line At Avastin Hearing

Executive Summary

Genentech and FDA’s Center for Drug Evaluation and Research seem to agree on one thing when it comes to deciding whether Avastin’s (bevacizumab) metastatic breast cancer indication should be withdrawn – the integrity and intent of the agency’s accelerated approval program are at stake.

You may also be interested in...

What’s In A PDUFA Reauthorization? Maybe These Issues…

What’s In A PDUFA Reauthorization? Maybe These Issues…

Accelerated Approval Remains “Viable Pathway,” FDA’s Woodcock Says

FDA’s accelerated approval program is alive and well now, and will remain a viable pathway in the future, despite concerns within the industry and investor communities that recent oncology regulatory actions are hastening the program’s demise.

Related Content





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