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


Roche’s Gazyva Clears FDA, But First Breakthrough Approval Breaks No Speed Barriers

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA cleared Roche’s Rituxan follow-on GA101 in roughly six months, the same amount of time as an old-school priority review.

You may also be interested in...

US FDA Biosimilars Staff Faces More Transition As Sue Lim Departs After Christl

Sue Lim, who serves as director of scientific review staff of the US FDA's Therapeutic Biologics and Biosimilars Staff, will be leaving the agency at the end of February to start an independent consulting firm.

A “Breakthrough” Reality Check: Sponsors Seek FDA Flexibility On Manufacturing, Diagnostics

FDA’s much-anticipated guidance on expedited programs for drug development fills in some blanks on the new breakthrough designation, but simply advising sponsors they will need to pick up the pace on manufacturing plans and development of companion diagnostics leaves aspiring applicants wanting more, stakeholders said at DIA.

CDER Approvals In January Came Early And Often

FDA started 2012 with a bang: five novel approvals in January, including two of the fastest approval times in modern agency history (and the fastest therapeutic approval outside of oncology), plus two big decisions on anti-diabetics.


Related Companies




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