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

UsernamePublicRestriction
UsernamePublicRestriction

FDA Accepts Onyx’s Carfilzomib Application But Denies Priority Review

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

“Our plan is to continue our dialogue with the FDA and see if we can address their concerns and get the accelerated approval done,” Onyx R&D chief Love told analysts. The company completed its application to treat patients with refractory and relapsed multiple myeloma in September based on results of a single-arm study, a design the agency may not be inclined to accept.

Advertisement

Related Content

“Emerging Sponsors” Pose Regulatory, Public Relations Challenges For Drug Review Process, FDA’s Jenkins Says
Onyx Files Carfilzomib For Accelerated Approval With Two Phase III Trials Ongoing

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS004882

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

Cancel