Pink Sheet is part of the Business Intelligence Division 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


FDA’s First “Breakthrough” Approval Coming; Won’t Break Speed Records

This article was originally published in RPM Report

Executive Summary

Genentech’s oncologic obinutuzumab is expected to be one of the first Breakthrough therapies approvals under PDUFA V. The data look game-changing for chronic lymphocytic leukemia patients. But will it result in a faster FDA review? Under the agency’s new review Program, probably not.


Related Content

FDA’s First “Program” Reviews: Fast Approvals, But Still Some Surprises
FDA’s “Breakthrough” Exceeds Expectations; Will It Break The Bank?
Time for Transparency: PDUFA V’s Big “Experiment”


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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