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

Keeping Track: CDER Ties Monthly Novel Approval Record With Nourianz Green Light

Executive Summary

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

You may also be interested in...



CDER Reviewers Showcase Speed In 2019 With 11 Novel Drugs Approved Within Six Months

Median review time held steady in 2019, but the percentage of NDAs the US FDA approved within six months jumped compared to recent years, a performance upswing all the more impressive because of the relatively high number of applications involved.

Keeping Track: Industry Beefs Up 2020 Review Pipeline With Submissions Galore

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

Lilly's Taltz Approved For AS As New Guidelines Keep TNF Inhibitors In Front Line

VP Rebecca Morison said the ankylosing spondylitis indication adds more evidence of Taltz's benefits. She noted Lilly believes there should be fewer steps before AS patients access IL-17 inhibitors.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

OM006665

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