Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Keeping Track: A Quintet Of Novel Approvals

Executive Summary

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

You may also be interested in...



Turning Point ROS1/TRK Inhibitor Repotrectinib Could Stand Out On Durability

The drug showed a high durability of response in ROS1-positive NSCLC patients, a factor that could give it significant differentiation compared with approved agents.

When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval

More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.

JAK-Inhibitor Review Delays Spur Talk Of US FDA Panel Meeting On Class Safety

After Pfizer saw increased risks in a surveillance study of Xeljanz, three other products have also seen their user fee dates pushed back; if FDA were to convene an expert panel, it could lead to more consistent labeling across the class, as requested in a recent citizen petition.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS140699

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

Cancel